SDRAN posts job applications for regulatory, quality, and clinical positions for free for firms in Southern California area only. Postings will remain on the website for at least 60 days. To place a job posting, please send a job description of around 200 words with contact information included in a word file to Greg Payne, SDRAN VP of Communications/Membership at gpayne1@cox.net

Philips Healthcare

Regulatory Affairs Specialist (9/03/2010) Join one of the leading Fortune 500 medical device companies in the world – Philips Healthcare. The Carlsbad location, formerly Respironics, is seeking a Regulatory Affairs Specialist for our ventilator business. Responsibilites: Serve as the regulatory representative on product development teams Prepare regulatory strategies to facilitate launch of new products in the US and internationally Provide regulatory guidance on standards, design controls and Quality Systems compliance issues Prepare domestic and international regulatory submissions Work with and respond to inquiries from regulatory agencies Develop/enhance regulatory procedures and processes Create Technical Files to the European Medical Devices Directive Review product changes against regulatory approvals Review labeling and promotional materials to ensure consistency with regulatory approvals Collaborate with project development teams to ensure deliverables for international registrations meet regulatory requirements Coordinate and oversee all operational and logistical aspects of RICA Field Actions Coordinates sending out all customer notifications and tracks them for FDA traceability Maintain tracking databases and status reports of all RICA field actions Submit periodic status reports to FDA, Competent Authorities and BU Perform device tracking audits to ensure compliance with applicable FDA regulatory requirements Education & Experience: BS in science or related discipline or equivalent experience Ability to deal with multiple tasks and complex projects Knowledge of GMP and Quality Systems requirements Strong understanding of US and International medical device regulations Experience with QSR, Compliance, 510k Submissions Recalls, ISO 13485, Device Tracking Contact: Theresa Hebert Sr. Recruiting Account Manager Philips Healthcare (425) 482-8452 theresa.hebert@philips.com

Leader Consulting & Recruiting

Regulatory Affairs Manager (7/20/2010) Our client is one of San Diego's premier biotech companies based in Sorrento Valley. They are currently seeking a Regulatory Affairs Manager with experience in the IVD industry. If you have excellent oral and written communication skills, solid computer skills and 8-10 years of experience in RA, including at least 4 in IVD, this is a great opportunity for you! This position acts independently to determine methods and procedures on new or special assignments and may supervise the activities of other lower-level personnel. Responsibilites: Participate on product development core teams as regulatory representative Interpret and apply regulations by creating regulatory strategies for domestic and international markets Prepare hardcopy and electronic information packages for submission to regulatory agencies Lead complex regulatory submission teams Provide recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance Review validation, clinical and stability protocols and reports for regulatory submission soundness Assess manufacturing process and labeling changes for regulatory reporting impact Define, monitor and receive deliverables for submissions Write and/or edit submission documents using regulatory templates, or create new templates Participate in Material Review Board and complaint/recall meetings Complete health hazard assessments for regulatory reporting of product problems; prepare regulatory agency information packages Keep informed of new and revised regulations; disseminate information as directed by management Interact with regulatory agencies, maintain correspondence and other records of interaction Assemble paper and/or electronic copies for submission Prepare internal procedures for continuous process improvement Mentor junior members of the department Provide regulatory guidance and/or training to external departments and marketing partners Assist in hosting inspections, as needed Assist in conducting internal/external audits, as needed Manage consultants, as needed Education & Experience: BS/BA degree or equivalentand a minimum of 8-10 years related experience OR MS degree or equivalent and 4-6 years related experience OR PhD and 3-4 years related experience Required Skills: Solid computer skills Advanced written and oral communication Experience and knowledge of IVD manufacturing For information about applying contact: Julie Leader HR Consultant Leader Consulting & Recruiting Carlsbad, CA 92011 760 845-1693 julie@leaderconsulting.com leaderconsulting.com

Gen-Probe

Sr. Regulatory Affairs Specialist / Manager (7/20/2010) “The Power to Look Deeper” Awarded the 2008 Grand Prize at the local Workplace Excellence Awards, Gen-Probe is a respected biotech employer of choice in San Diego and a global leader in the research, development, manufacturing and marketing of nucleic acid probe-based products used for the diagnosis of human diseases and for screening of donated human blood. We offer a state-of-the-art facility in a prime location with world-class benefits. We’re currently looking for team members who have “The Power to Look Deeper” in developing the best products, technologies and service. “The Power to Shape Your Future” We are seeking a Sr. Regulatory Affairs Specialist / Manager who will define, manage and execute complex, global regulatory submission strategies to help meet growing post market compliance and change control activities. Candidates should have some international regulatory experience and familiarity with the IVD industry. Responsibilites: Make regulatory recommendations regarding compliance activities, including MRB, recall/complaints and specifications Identify, interpret, and apply the appropriate/relevant regulations to support domestic and international product commercialization Develop and maintain process for assessing and implementing compliance activities in response to new/emerging international regulations Education & Experience: BA/BS and 5+ years related Regulatory Affairs experience required IVD experience with CDRH and international regulatory experience required Applying: Gen-Probe offers a dynamic and innovative work environment along with excellent benefits that include company sponsored medical/dental/vision benefits, stock options (NASDAQ:GPRO), bonus potential, 401(k) with company match, paid vacation/sick time /holidays, assistance with continuing education, on-site fitness center and our own Waterfall Café. We invite you to view our Career Video! View Video Please apply online by visiting: genprobe.com

CareFusion

Advisor, Regulatory Management (Senior Specialist) (7/15/2010) Every day at CareFusion, we work to improve patient care. By combining clinically proven products and services with actionable intelligence, we're helping to solve some of healthcare's most difficult challenges Regulatory Management is responsible for development and deployment of policies and programs to minimize risk and enable compliant business operations. Expectations : Demonstrates in-depth experience with applicable laws, regulatory agencies and technologies Evaluates the effectiveness of programs, policies and procedures Evaluates and mitigates risks Management Function: Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results Uses deep subject matter/functional expertise, influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications Encourages informed Risk-taking and acts as a catalyst for innovation at CareFusion; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources Champions and leads change initiatives; identifies the best approach for implementing strategic processes in light of cultural and diversity Duties: Develops regulatory strategy, prepares, submits and maintains domestic submissions Develops, prepares, submits and maintains international regulatory submissions Reviews protocols for product design documentation. For example, Simulated User Trials and Customer Preference Trials for compliance to the submission strategy Reviews domestic and international labeling for compliance to labeling requirements, including content, format, 510(k) impact, etc. Provides regulatory/labeling support for International CE product marking and regulatory submissions Reviews medical/scientific literature to support 510(k), labeling, and clinical strategy Reviews and approves product risk assessments Reviews and approves product design changes Coordinates recall activities. Develops and maintains tracking information for product recalls SAP system resource for regulatory events such as recalls, labeling, etc Responsible Regulatory lead for Review & Approval of Post Release NCMR's Provides regulatory guidance as needed Qualifications: Bachelors degree and minimum of 3-5 years related professional experience; equivalent combination of education and experience Knowledge of current FDA regulatory requirements and trends for medical device Premarket Notifications Good prioritizing, organization, interpersonal, communication and analytical skills. Knowledge of software, instrument and disposable design practices Knowledge of ISO / MDD and Canadian regulatory requirements. Ability to influence and work with personnel at all levels and functional boundaries. Ability to represent Regulatory Affairs in multiple environments (i.e., Marketing, R&D, etc.) For information about applying contact: Patrick Monteforte Recruiter Talent Management - Staffing CareFusion 3750 Torrey View Court San Diego, CA 92130 858.617.2272 direct Fusing technology and intelligence to improve patient care

Advanced BioHealing

Sr. Manager/Associate Director Regulatory Affairs - Biologics (7/06/2010) Job Summary: Manage regulatory projects for biologic cell-based products, including major, complex applications submitted to global regulatory agencies. Develop effective proactive regulatory strategies for global product development with limited oversight. Ensure that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements. Incumbent may lead and assist in assessing, coaching, and developing the Regulatory Affairs and project teams. Ensure appropriate partnering within the business, including Medical, Quality, Marketing, and Operations. Title will be commensurate with experience. This position has supervisory responsibilities. Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Mathematical Skills: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form Certificates, Licenses, Registrations: RAC certification preferred. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Primary Duties and Responsibilities: Lead/manage complex projects which requires coordination of cross-functional resources and strategic management of competing priorities that have a direct impact on site operation Provide input and review of regulatory requirements, project risks, and prepare submissions and facilitate their approval. Manage resources for submission preparation and communication with internal/external customers to achieve all phases of product approval and commercialization of products Participate in project teams to manage activities and/or changes related to product development, manufacturing, and commercialization. Provide review of and input to development plans. When appropriate, provide strategic guidance for problems being discussed and recommend solutions Support review of safety reports; prepare and submit adverse event reports as required to the FDA and/or appropriate government agencies Hands-on RA representative on product development teams. Coaches others on technical, scientific, and clinical aspects of regulatory submissions and facilitates the sharing of critical research and development information Identifies and drives continuous improvement in support of quality standards and business results. Provide guidance on regulatory issues and procedural recommendations for standard operating procedures and protocols. Guides and coaches others in the appropriate application of regulations and standards related to submission preparation and commercialization, product and labeling compliance Review product labeling and advertising materials for compliance with approvals and applicable global regulations; analyze and recommend appropriate changes Collaborate with Quality Assurance to manage programs and ensure regulatory compliance with product development, validation, and commercialization activities subject to regulations established by US, EMEA, and other worldwide governments (as required) Interact with outside consulting groups and manage activities necessary for completing key initiatives. Provide mentoring to current staff and have skill sets for directly managing staff Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BS degree in life sciences or related scientific discipline, prefer advanced degrees Minimum of 10 years of relevant experience in the biotech industry required Minimum of 6 years regulatory experience in develop strategies, planning and publishing regulatory submissions required Regulatory experience with development of Biologic products required and proven experience with IND and BLA submissions and negotiations with FDA staff Experience with working on clinical studies across the regulatory spectrum from Phase I to post-approval Must have a good working knowledge of relevant regulations Previous manager-level experience, including supervisory experience required Strong organizational, interpersonal and written/verbal communication skills Preferred Experience: Experience with the development of cell-based products a plus Experience with the development of products in the area of tissue repair/regenerative medicine with an emphasis in soft tissue/orthopedics Applying: We offer a competitive benefits & compensation package! All qualified resumes should be submitted directly to careers@abh.com We are an Equal Opportunity Employer.

Validation Engineer II (7/06/2010) Summary: Responsible for the calibration and validation of equipment and systems. Assists in equipment selection, and specification, as well as the selection of validation services. Responsible for all documentation pertaining to qualification and validation. Develops procedures and protocols. Also serves as information resource for Associate/Validation Engineers, contractors, vendors and internal customers. Works on qualifying installed systems and software. Work may include complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. May determine methods and procedures on new assignments and may provide guidance to other personnel. Supervisory Responsibilities: May provide guidance to other validation personnel for specific projects as assigned by Manager. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and Experience: BS degree in a scientific Engineering/ discipline or equivalent with 4 + years related experience. Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals in English. Ability to write routine reports and correspondence in English. Mathematical Skills: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to define problems, collect data, establish facts, and draw valid conclusions. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be able to lift 40 lbs. Must be able to gown and work in cleanrooms. Essential Duties and Responsibilities: The duties and responsibilities of this position include the following, although other duties may be assigned. % of Time       Job Task       5                Manage Validation Programs      30               Execute selected studies and protocols for equipment or systems      35               Write selected studies, protocols, and reports for equipment and systems      20               Calibrate and setup validation equipment      10               Keep abreast of current technology by attending professional meetings and seminars and                            reading technical literature Knowledge: (Indicated special knowledge/areas of expertise required) Validation Fundamentals Calibration Fundamentals Microsoft Excel Microsoft Word Current Validation Technology/Requirements Working knowledge of software validation Understanding and experience in Software Validation Familiar with equipment to include: Temperature freezers, boilers, airhandlers and cell mates Familiar with document control systems preferred Skills/Abilities: (Includes technical, administrative and behavioral skills) Good written skills required for writing protocols and standard operating procedures Good communication skills required for interactions with internal departments and outside vendors and contractors Analytical thinking/ Judgment Appplying: We offer a competitive benefits & compensation package! All qualified resumes should be submitted directly to careers@abh.com We are an Equal Opportunity Employer.

QA Engineer (7/06/2010) Summary: Responsible for supporting product qualification, process validation, quality planning, Nonconformance / Corrective Action assessment and tracking, Complaint Handling, Technical Engineering Support for all Quality Assurance functions associated with the product(s) of this company. Revisions to current and proposed products / systems will be identified and assessed by the incumbent as required to ensure compliance to company policies and cGMP’s. Certificates, Licences, and Registrations CQE, CQA highly desirable. Education and Experience: Bachelor's degree in Engineering, Quality, Science or Technical Discipline and a minimum of four-years of experience in a Quality Engineer Position in a GMP/QSR related industry. Strong knowledge of FDA Quality Systems Regulation, ISO, and other International Quality System Regulations. Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Physical Demands: Position requires incumbent to work with personal computers performing keyboarding / typing and data entry. Some lifting of boxes is necessary. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualifications: Experience with FDA (or other regulatory) inspections Experience in Aseptic Manufacturing Hands-on SPC, design of experiments, risk management, FMEA (use design and process), statistical sampling techniques, process validation (IQ/OQ/PQ), test method validation, Gage R&R, etc. Proficiency with FDA regulations (QSRs), ISO 13485 required; knowledge of ICH guidelines preferred Excellent written / oral communication skills, focused self-starter, attention to details, team-oriented but able to work independently and proactively, and ability to multitask Working knowledge of MS Word, Excel, PowerPoint and Project Working knowledge of an electronic document management System Ability to travel (10%) Familiar with document control systems preferred Duties and Responsibilities Responsible for Corrective and Preventive Action (CAPA) Program, NCMR System, Deviation System, Out of Tolerance, and Facility Incident Notices. Follow-up on completion of corrective actions to ensure timeliness and CAPA effectivity. Update databases; prepare metrics, present trending and tracking at Management Review Meetings Review / Approve Validation Protocols and Reports (IQ, OQ, PQ), studies, etc. Review / Approve rework of Product Conduct customer complaints investigation, including identifying root cause of the complaints, determine appropriate corrective and preventive actions, and trending Work very closely with Customer Service, Process Development, and Manufacturing Engineering to resolve customer complaints, including performing statistical data analysis, trending and presenting data to management for action Maintenance of Quality Systems to current regulations. Support FDA, FDB, Government inspections, and International Regulatory Inspections, preparations and corrective actions as needed. Assist in Internal Audits, recalls, and removals as needed Appplying: We offer a competitive benefits & compensation package! All qualified resumes should be submitted directly to careers@abh.com We are an Equal Opportunity Employer.

Regulatory Affairs Specialist (7/06/2010) Summary: This position will assist with the preparation and submission of regulatory documents and will provide support of the regulatory function with respect to database management, maintaining regulatory files and licenses, and assisting on assigned projects as needed. May prepare reports or specific sections of INDs, IDEs, CTAs, PMAs, BLAs or other regulatory documentation under supervision. May submit submissions or variances for changes for labeling, manufacturing, marketing, or clinical protocols. Keeps abreast of regulatory compliance issues and assist in developing new Regulatory Dept. procedures. This individual will maintain registrations and licenses for the company and will prepare periodic reports as directed by the department head. Education and Experience: High school diploma or equivalent; BA/BS in life or health science desirable. 0 to 2 years of regulatory or related experience in a biotech or medical device company. Familiarity with U.S. FDA medical device and/or drug approval process. This should include a general understanding of applicable regulations. Understanding of GMPs and GCPs would also be helpful. Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.. Mathematical Skills: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May include standing at photocopier and some light lifting (up to 10 lbs.) when working on regulatory submissions. Involves working in normal office environment. Some travel may be required up to 5%. Certificates, Lienses, Registrations: Certificate in Regulatory Affairs, US or EU RAC Certification mandatory for those without direct regulatory experience. Duties and Responsibilities: Assists and supports Regulatory team with projects associated with product submissions development. Performs the coordination and preparation of document packages for regulatory submissions and interfaces with various functional areas to collect relevant information, test reports, and technical discussions Compiles all materials, prepares and submits applications for relevant State and federal licensing and registrations, and annual reports. Researchs international and domestic regulatory issues Maintains regular communication with team members to facilitate international registrations and approvals Other duties and responsibilities that may be assigned from time to time. This may include review of labeling and promotional materials, maintenance of complaint files and attendance at meetings as the regulatory representative Support the development and review of documentation and procedures to support the regulatory function Qualifications: Must have strong computer skills and be proficient using network software Should possess strong writing and verbal skills Must be flexible in work assignments - can involve collaborative team settings to specific individual projects Ability to comprehend and interpret material and issues of a scientific or technical, and communicate those facts and concepts verbally and in writing Must be responsive to requests from international colleagues Must demonstrate ability to work independently Must represent the regulatory function with integrity and professionalism Certificate in Regulatory Affairs, US or EU RAC Certification mandatory for those without direct regulatory experience. Must be well-organized, and be able to adapt to changing priorities and deadlinesAnalytical thinking/ Judgment Appplying: We offer a competitive benefits & compensation package! All qualified resumes should be submitted directly to careers@abh.com We are an Equal Opportunity Employer.

Leader Consulting

Regulatory Affairs Consultant (6/30/2010) Leader Consulting specializes in talent acquisition for the medical device community. Our client is a super medical device start-up company in North County San Diego and they are currently seeking a Regulatory Affairs Consultant. This is a terrific opportunity for someone with 5-10 years working in RA in the medical device industry. Reporting to the CEO, the primary accountability will be obtaining the CE Mark by December and filing the 510k in early 2011. Consultant will drive the process, extract the necessary information from other staff members, pull the appropriate documents necessary to achieve the CE mark, and write & file the 510k. Estimated time requirements would be about 20-30 hours per week now, and 40 in the fall. The position could possibly transition to full-time regular later in the year if the person is interested, or remain as a consulting role until projects are complete. Responsibilities: Provide regulatory support and guidance to project teams and senior management Prepare and submit FDA and European submissions for approval Manage process from development of regulatory strategy through to approval Conduct internal regulatory audits and ensure compliance with all U.S. and international regulatory requirements pertaining to product approval Maintain relationships and act as liaison with Authorized Representatives, FDA reviewers, Notified Bodies, external regulatory legal counsel and regulatory consultants Review complaints and lead vigilance and MDR reporting efforts Review and advise on promotion and advertising materials, labeling, product claims, training materials, publications, press releases or marketing programs to ensure compliance with regulations Minimum Requirements - Education, Skills, Experience: Minimum BA/BS or equivalent in the Life Sciences, Engineering or related area Must have a thorough understanding of RA standards, practices, and regulations Must be able to represent own area well, while taking positions and actions based upon a broad view of the company Must be able to work independently and hands-on in a timeline driven startup environment Must have excellent written and oral communication skills. Requires the ability to write reports and business correspondence Working knowledge of PC applications such as MS Word, Excel, Project and PowerPoint 5-10 years RA experience in a medical device company Must have successfully lead effort to file and receive clearance for a medical device 510(k). Experience with a 510(k) involving clinical trials is a major advantage Experience in gaining CE Marking is helpful For information about applying contact:: Julie Leader HR Consultant Leader Consulting & Recruiting Carlsbad, CA 92011 760 845-1693 julie@leaderconsulting.com

Herbalife International of America, Inc.

Regulatory Affair Specialist / Product Licensing Specialist (6/30/2010) Job Summary Works in a cross-functional environment to obtain and maintain registrations and/or authorizations necessary for commercialization of food, food supplements, dietetic products, energy drinks and personal care products in countries of responsibility. Responsible for the development of printed components in countries of responsibility. Assists with the response to technical & regulatory inquiries or complaints. Supervisory responsibility over projects is required. Occasional training of temporary and new staff members may also be required. Detailed Responsibilities/Duties: Demonstrates knowledge of national & regional regulations, dossier preparation and registration/notification requirements for countries of responsibility Effectively interacts and communicates by e-mail, fax, telephone calls with attorneys, consultants, manufacturers and other departments on a daily basis with regard to all aspects of the product lifecycle Assists with the review of new preliminary and concept formulas to determine ingredient acceptability and appropriate product classification in countries of responsibility Develops new printed components with label & artwork and completes regulatory review of the final artwork As required, prepares technical dossiers for individual products to be reviewed and evaluated by country officials for product approval. Requests and prepares supporting technical and non-technical data from manufacturers, technical library and various departmental sources Assists with the creation of new SKU's, setup of the Bill of Materials (BOM) and completion of the product release. Responsible for confirming formula and label acceptability, as well as the receipt of necessary licenses, prior to approving the product to the 'Production' lifecycle Maintains and renews existing licenses for all products in countries of responsibility Initiates and drives changes for items (raw materials, formulas, printed components, SKU's) through the database system Prepares concise reports of all varieties through the database system. Assist with the validation of data for countries of responsibility, for use in all reports and queries Keeps abreast of general & product-specific regulatory developments in countries of responsibility. Communicates those issues in a timely fashion to management, along with initial thoughts or suggestions Carries out all responsibilities in an honest, ethical and professional manner Skills/Education/Experience: Required Bachelor's degree in nutrition, biology, chemistry, food science, pharmacy, legal or related field Must be fluent in Spanish oral and written communications Detail-oriented with the ability to analyze complex technical data Excellent organizational skills and ability to multitask Excellent oral and written communication skills in English Ability to analyze problems and come up with creative solutions Team player with good people skills Ability to adapt in a fast-paced setting with evolving goals and objectives PC skills (email, word-processing, spreadsheets, etc.) Preferred Knowledge of foreign language Some industry or related work experience Applying: Apply at herbalife.taleo.net Job # 090939

Tandem Diabetes Care, Inc.

Vice President, Quality (6/30/2010) Job Summary Responsible for implementing the company's Quality strategy and policy development, and for directing the functional resources for the company. Develops, implements and communicates the company's Quality strategy and programs, including Quality Assurance and, on a broader basis, Total Quality Management throughout the organization. Translates the company's Quality strategy into tactical policies, processes and procedures to meet global regulatory, medical/health and legislative standards. Promotes recognition of company quality programs among customers, as well as develops and implements employee communication and training programs in connection with Quality objectives, strategies and processes. Position Requirements BS, MS, or PhD in life sciences or equivalent experience with a minimum of 15 years related experience in medical device with thorough knowledge of current FDA regulations; at least seven years in a senior managerial capacity; and experience in a start-up environment building out a successful organization. Requires knowledge of foreign regulations pertaining to the manufacture and distribution of medical devices, lean manufacturing processes, computer and equipment qualification and validation, GMPs, ISO, product/process validation, Master Control database management, and statistical evaluation techniques. Experience in manufacturing high volume disposables and Electronics in a clean room environment is preferred. Requires experience leading and managing a QA team through the various stages of product development and clearance/approval, interacting with US and international regulatory authorities or notified bodies, and implementing Quality systems, including certification processes. Accountabilities Works on abstract problems across functional areas. Identifies and evaluates fundamental problems for major functional areas through assessment of intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria for managing areas of responsibility and accomplishing overall project goals. Erroneous decisions will have a long term effect on the company’s success. Interacts internally and externally with executive level management, FDA, and international regulating bodies requiring negotiation of extremely difficult matters to influence policy making. Responsibilities: Oversee the development, implementation, maintenance, and reporting of the Quality Management System and training on all Quality programs through the management review process to ensure the continued suitability, compliance and effectiveness of the Quality Management System Serve as the Management Representative for the company Oversee compliance with FDA MDD, TUV, ISO 13485, and similar regulations and manage inspections by regulatory agencies and bodies Manage company’s Incident and Complaint and CAPA processes, including failure investigation tracking and trending activities, reporting, and CAPA implementation effectiveness Advise relevant corporate personnel regarding Quality strategies, potential areas of concern, and new and upcoming governmental/regulatory developments Direct all regulatory submissions and registrations to foreign governments and agencies, and participate in product registration process with distributors and affiliates, for international product distribution Develop and implement audit plans and audit schedules for internal and external compliance audits of raw material suppliers, contractors, collaborators, and other relevant organizations; recommend and assists in preventive and corrective actions, as required Define Quality strategies for products in development and provide guidance to product development teams Participate in the review and prioritization of projects/portfolio Ensure labeling, advertising and other promotional materials are in compliance with regulatory requirements Ensures that internal and external quality assurance documentation adequately evaluates products and processes, including submissions to regulatory authorities; develops and implements required modifications Coordinate with Engineering, Operations, and others in the development of Design History File, Device Master Record, and other required design transfer data and systems to ensure integrity and quality of submitted data Collaborates with research and development through entire product realization efforts: establishes key test and inspection methods for new products and processes; manages QA release of products for commercialization Oversee Quality Assurance programs, staff, and budget Applying: Apply at tandemdiabetes.com

AutoGenomics, Inc.

Manager, Regulatory/QA (6/30/2010) Responsibilities: Prepare domestic and international registration/licensing submissions Prepare regulatory submissions to support product clearance/approvals (e.g., IDE, 510(k), PMA, Technical Files) Review product labeling QA release of products for distribution Review product and process changes to assess impact on domestic and international submissions Validation (e.g., Software, System) CAPA and Complaint process Manage quality audits Other duties as assigned Requirements: B.S. degree or equivalent 3-5 years within the medical device industry in a regulatory/QA role; FDA pre-market submissions [510(k), IDE, PMA]; CE marking FDA QSR, ISO 13485, IVDD, FDA MDR, and EU Vigilance Good interpersonal skills Good oral and written communication skills Good computer skills Project management Ability to multitask and work within a fast-paced dynamic team environment For information about applying contact: Corrine Riffaud e-mail: criffaud@autogenomics.com

Scantibodies Laboratory, Inc.

Manager of Regulatory Affairs (6/17/2010) Scantibodies Laboratory, Inc., one of the largest Biotech companies in San Diego is currently recruiting for a Manager of Regulatory Affairs. Description: Ensure that Scantibodies obtains and maintains all regulatory approvals of products and facilities. This person is a key driver of change within Scantibodies and is heavily focused on Improvements to products and processes. Experience must include 510K filings for in-vitro diagnostic devices or medical devises, Submission of pre-IND, IND, NDA/BLA applications for drugs and biologics, developing a regulatory strategy for the regulated products which ensures compliance with regulations and marketability of products. Management of Department personnel. Requirements: Bachelors Degree Minimum of 7 years experience in regulatory affairs in similar industry Knowledge of GMP/QSR and ISO international regulations and standards which apply to SLI Computer literate in MS Word and Excel and possess excellent communication skills Qualifications: BS degree 10+ years’ relevant experience 3+ years' in-house experience Strong CRO experience Benefits Include: Medical Dental 401K with company match Tuition reimbursement and incentive compensation Applying: Visit our website at scantibodies.com

Simply Biotech

Principal CPA (6/17/2010) Simply Biotech specializes in recruiting exclusively for San Diego's biotech community. We are currently seeking a Principal CRA for a leading and growing San Diego biotech firm. The qualified Principal CRA will be responsible for selection, oversight and management of clinical staff assigned to monitor and manage diagnostic and therapeutic clinical studies - design, implementation, management, and coordination - across multiple clinical programs. The selected candidate will ensure the conduct of all studies and projects within the diagnostic and therapeutic clinical programs is in accordance with Good Clinical Practices (GCP) and company Standard Operating Procedures (SOPs). Responsiblities: Ensuring consistency and harmonization of all clinical studies within the clinical program Selecting, supervising and directing Clinical Trial Document Specialist (CTDS), CRAs, Sr. CRAs assigned to clinical study or studies across one or more clinical programs Working closely with Program Managers to allocate and assign appropriate clinical resources (CTDS, CRAs, Sr. CRAs) to monitor and manage studies/projects Providing line management of CTDS, CRAs, and Sr. CRAs, including training, mentoring, and career development Providing input in identifying/evaluating/selecting the vendors or Contract Clinical Research Organizations (CRO), including delegation of responsibilities to the CRO Providing review and input into development of key clinical operational documents/plans such as monitoring plans and laboratory manuals as needed Providing input in identifying, qualifying, and selecting clinical sites and investigators to conduct trials Managing the initiation, monitoring, coordination of study conduct and completion of diagnostic and therapeutic clinical trials across clinical programs Ensuring Trial Master Files (TMFs) are maintained for each study, and all processes are conducted according to applicable Standard Operating Procedures (SOPs) Providing leadership and strategic planning for clinical programs and working closely with the program managers Qualifications: BS degree 10+ years’ relevant experience 3+ years' in-house experience Strong CRO experience Applying: For immediate and confidential consideration, please email your resume to info@simplybiotech.com or call 858.487.0507 More information can be found at simplybiotech.com

Biosite Inc.

Director, Regulatory Affairs (6/12/2010) Requirements: Biosite Inc. is seeking a gifted regulatory leader with approximately 10 years experience leading a regulatory function in the biotechnology industry. This person must be a skilled enabler, team builder, and mentor. This person must be able to demonstrate in-depth knowledge of regulatory issues and processes affecting biotechnology in general, and diagnostic tests/devices in particular. This person must be able to demonstrate effective project management skills, and efficient multi-tasking skills. This person must know how to establish credibility with scientific experts and business leaders. Description of Position: The person in this position will lead all regulatory employees and activities for Biosite Inc. This person will be responsible for interacting with regulatory agencies, and translating regulatory requirements into a workable strategy/plan. Responsiblities: Setting up and operating a smoothly-running regulatory function Evaluating, selecting, and developing regulatory personnel capable of fully functioning as a credible representative for the Regulatory Affairs function Evaluating, selecting, and developing regulatory personnel capable of compiling scientific information, completing regulatory applications, and coordinating/managing the application and approval process Overseeing all annual registrations and license renewals Obtaining the earliest possible regulatory approvals for our medical technologies and devices Providing regulatory expertise to executive management (business, scientific, and operations/manufacturing executives) Coordinating, collaborating, and participating with Quality function in all internal and external audits Functioning as a subject-matter expert for other regulatory personnel Applying: Contact dstreich@biosite.com about applying.

Ardea Biosciences, Inc.

Clinical Data Manager (6/12/2010) Ardea Biosciences, Inc. is a biotechnology company focused on the development of small-molecule therapeutics for the treatment of gout, cancer and human immunodeficiency virus (HIV). We presently have product candidates in Phase 2 clinical development and our next generation inhibitor program is currently in preclinical development. Our lead product candidate for the treatment of cancer is being developed under a global license agreement with Bayer HealthCare AG. Two product candidates for the treatment of HIV have successfully completed a Phase 2a study in HIV patients and a human micro-dose pharmacokinetic study in healthy volunteers. Job Summary: The Clinical Data Manager (CDM) is responsible for the oversight of Data Management activities performed by CROs that are part of clinical studies conducted by Ardea. Primary Duties and Responsibilities: Review Clinical Study Report drafts and shells for accuracy and completeness and provides feedback to the clinical team and the CRO Review Study Tables, Listings and Figures and provides feedback on data and programming Develop summaries, presentations and spread sheets of clinical data as needed to fulfill requests from the clinical team or development partner Review Data Management Plans (DMPs) and associated documents for accuracy and completeness, based on the study Protocol and Case Report Form (CRF), and provides feedback to the clinical team and the CRO Review Statistical Analysis Plans in comparison to the study Protocol and CRF and provides feedback to the clinical team and the CRO Periodically review the effectiveness and quality of the Data Management work performed by CROs and provides feedback to correct issues; suggests improvements Ensure that Data Management deliverables from CROs adhere to established Ardea standards and scope of work Provide input to the design of CRFs for clinical studies Review all deliverables for Electronic Data Capture (EDC) system development and implementation and provides feedback to the clinical team and the CRO/EDC vendor Provide support to study teams for all Data Management issues and questions and suggests solutions Carry out job responsibilities and assignments safely and maintains a clean and safe work area Preferred Requirements: Bachelor’s Degree in Life Sciences or related field Minimum of 7 years experience in Clinical Data Management, including support of Phase 3 studies Experience in CRO management/oversight Experience with EDC system development and deployment Applying: Apply at ardeabio.com

Medical Writer (Contract) (6/12/2010) Ardea Biosciences, Inc. is a biotechnology company focused on the development of small-molecule therapeutics for the treatment of gout, cancer and human immunodeficiency virus (HIV). We presently have product candidates in Phase 2 clinical development and our next generation inhibitor program is currently in preclinical development. Our lead product candidate for the treatment of cancer is being developed under a global license agreement with Bayer HealthCare AG. Two product candidates for the treatment of HIV have successfully completed a Phase 2a study in HIV patients and a human micro-dose pharmacokinetic study in healthy volunteers. Job Summary: The Medical Writer will be responsible for producing documents for regulatory submission, as well as assisting with the development of clinical documentation. This individual will be responsible for final compilation of INDs, BLAs and NDA’s and may also support Clinical Operations in creating and adhering to a template/style-guide for clinical protocols, investigator brochures, and study reports. Primary Duties and Responsibilities: Create and/or update Investigator Brochures, clinical protocols, clinical study reports, safety narratives, and correspondence with regulatory agencies in agreement with predefined, aggressive timelines Organize production of INDs, BLAs, or NDAs in collaboration with Regulatory Affairs and other team members Evaluate draft documents and draft statistical output for accuracy and consistency Responsible for researching, writing and editing clinical reports, summarizing data from clinical studies for submissions to the FDA and for publication and/or presentation Will also assist in the development of formats and guidelines for clinical documentation QC tables, listings and figures, and clinical study reports provided by the CRO Other duties as may be necessary Preferred Requirements: Bachelors, Masters, or PhD in a relevant field Minimum 5 years of regulatory medical writing experience Minimum 5 years experience in the biopharmaceuticals industry Experience with producing INDs, BLAs, or NDAs in CTD format Excellent writing and interpretive skills Must have working knowledge of ICH E2 and E6 plus CFR 312 and 314 Knowledge of Canadian and/or EU regulatory requirements is preferred General knowledge of applied clinical medicine and laboratory interpretation Experience with small-molecule drug development is preferred Experience with an electronic document control and management system Proficiency in strategizing, planning, monitoring and problem solving Team-oriented with excellent communication and interpersonal skills, demonstrated ability in managing indirectly Ability to manage multiple and diverse issues Strong facilitation, organizational, analytical and time management skills Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and MS Project. In particular, working knowledge of MS Word 2007, ISI Writer Templates, EndNotes software and AMA Style guidelines are required Ability to apply knowledge to new situations Effective communication skills and ability to articulate complex and broad concepts and translate into plans for action and constructive improvement Appplying: Apply at ardeabio.com

Amylin Pharmaceuticals Inc.

Lead Auditor, Corporate Quality (6/09/2010) Amylin Pharmaceuticals Inc. is seeking a Lead Auditor, Corporate Quality to plan, organize, and conduct GMP audits and manage oversight of GXP (GMP, GLP, CAP-CLIA) and GXP Support compliance audits of external contract service providers. This position is responsible for ensuring audit schedules are generated and followed, quality metrics are generated, and audit related corrective actions are assigned to appropriate individuals. Responsiblities: Initiate and maintain annual GXP Audit Schedules Organize audit teams, plan, schedule, and conduct external GMP compliance audits Oversee GXP (GMP, GLP) audit responsibilities contracted to outside vendors Work with other Amylin auditors to ensure audits are assigned, completed, as scheduled Generate written audit reports and route to responsible persons for review and approval Distribute audit reports and follow-up on receipt of audit responses from internal and external sources Review and approve audit related corrective actions and assign to responsible individuals using an electronic tracking system (Trackwise®) Attend periodic Quality Lead Team meetings and serve as a representative and/or lead on one or more of these teams Provide audit related metrics and presentations to the Quality Lead Teams and Quality Review Board Provide support to Corporate Quality in FDA audits, internal inspection readiness activities, Quality Improvement Plan, Notifications to Management and compliance related projects In support of establishment of an annual budget, provide input to Corporate Quality Management on upcoming audits Perform formal risk assessments on selected contract service providers, to determine audit intervals and establish a level of risk Participate in Operation Excellence projects Initiate, revise and author audit related company Standard Operating Procedures, as required Perform all responsibilities in accordance with company guidelines and Standard Operating Procedures and appropriate industry and regulatory standards, guidelines, rules, and regulations Requirements: BS in a scientific or related discipline and 6 years related experience, or at least eight years of GMP auditing with management experience is required A Certified Quality Auditor (CQA), or similar certification is highly desirable At least 6 years work experience in Quality Auditing in a pharmaceutical manufacturing or contract service provider environment Strong GMP auditing experience needed Experience in vendor management and oversight of contracted audits highly preferred Requires a detailed understanding of industry auditing practices to FDA GMP (21 CFR part 11, 58, 210, 211, 820), GLP (OECD and JMHW), and CAP-CLIA Regulations Good interpersonal, communication, and writing skills are required Observe processes and interpret compliance risks is essential General office computer skills are necessary to provide electronic reports, graphs, and presentations Applying: To view a full job description and apply, please go to amylin.com/careers Amylin is proud to be an equal opportunity employer.

Biomerieux

Specialist, Regulatory Affairs (5/26/2010) Primary Duties - To administer and maintain policies and programs to ensure compliance with US and international regulations as applicable to bioMérieux products. Context of the job and major challenges - Responsible for the coordination and preparation of complex regulatory submissions and technical files for new and existing products. Ensures timely preparation of organized and scientifically valid submission. Interacts directly with regulatory agencies on specific product submissions. Evaluates and approves proposed changes to products and controlled documents. Reviews and approves labeling and promotional material. Evaluates reports of internal and external problem products and assists in product investigations to determine the need for field corrective action. Provides advice to and represents RA on specific project teams. Creates, monitors and controls Regulatory project schedules. Monitors change in the regulatory environment, valuate impact and communicate to interested parties. Main Accountabilities Promote appropriate regulatory strategies and routes in order to obtain expeditious product approvals. Ensure that these strategies are communicated to the project teams and that they are implemented appropriately Participate in the preparation of various regulatory submissions/files for product approval/registration and ensure that they are completed in an accurate and timely manner. This responsibility includes all FDA submissions, all IVD technical document files as well as any other required registration activities for governments outside of the U.S. or the E.U. Participate in discussions and negotiations with the FDA and other regulatory agencies as required. Negotiate with regulators to ensure the proper treatment of bioMerieux products, and advocate the company’s position with regard to new or changed regulations Ensure that the Department’s Regulatory Policies and Procedures accurately reflect the rules and regulations of the various Regulatory bodies in the areas we commercialize our product. This includes but is not limited to the U.S. FDA, European Union, Japan, and Canada. Ensure the adequate implementation of RA policies and procedures and that all personnel who require training are trained. Prepare new RA departmental procedures or Policies and update existing procedures and policies as needed Provide insight and regulatory input to various functional groups within the Company Maintain familiarity with appropriate US and International governing statutes and regulations to ensure Company Regulatory compliance a) Monitor FDA activities and new initiatives for impact to the Company b) Participate/attend external association meetings, workshops and seminars (e.g. RAPS, ADVAMED, NCCLS,     NCRAF, NCCSQA, etc.) Provide recommendations to Executive Management with respect to the need for Recalls/Field Corrective Actions. Ensure that any recall/field corrective action is executed as planned and that the FDA and other regulatory agencies are notified as appropriate. Ensure that accurate records of the action are maintained Approve all Medical Device Reporting (MDR) reviews and ensure that the appropriate decision with respect to filing has been made. Ensure that MDR are filed within the mandated timeframes Represent bioMerieux during FDA inspections as needed Ensure that appropriate reviews of Labeling and Advertising materials are conducted within the department and that these reviews are in accordance with current FDA interpretation of the Regulations in this area Experience: Bachelor’s degree in a scientific discipline or equivalent combination of education and experience Minimum seven years regulatory experience in medical devices; In-Vitro Diagnostic devices required, minimum three to five years experience required Excellent verbal and written communication skills required International registration experience desired Experience in Labeling reviews, 510K/PMA submissions, and Regulatory compliance required Good negotiation and diplomacy skills Must have good PC skills and be proficient in Office Windows, particularly Word and Excel Excellent organizational and presentation skills required Applying: Location: St. Louis Contact: Shawn.Oberreiter@bioMerieux.com

Simply Biotech

Regulatory Affairs Specialist/Manager- IVD (5/24/2010) Simply Biotech specializes in recruiting exclusively for San Diego's biotech community. We are currently seeking a Regulatory Affairs Specialist/Manager for a leading and growing San Diego biotech firm. This position is a 5 months contract and may be converted to a full-time position. The qualified Regulatory Affairs Specialist/Manager will be responsible for leading RA projects and will work as part of the Regulatory Affairs department by aiding in the preparation of documentation for international and domestic product registrations, permits and licenses. The selected candidate will also participate on product development teams and/or help with field corrective actions. Additionally, this candidate will assist in the evaluation of change control documents, advertising and promotional materials, product labeling, and training materials while participating on internal/external teams involving regulatory review, approval and feedback. This may include complaint handling, corrective and preventive action, audits, training, recalls, field corrective actions, MDR/MDV, etc. Duties: Support the Regulatory Affairs team by implementing product-related regulatory strategies and by aiding in the provision of regulatory guidance on change control, risk analysis, labeling, and other relevant subject matter to ensure ongoing compliance to domestic and international standards for responsible product(s)/product lines Aid in the preparation of U.S. regulatory submissions to include the communication of product regulatory status and interfacing with Regulatory Affairs management. Responsibility for monitoring changing regulatory requirements, preparing comments, apprising RA management of new developments and preparing processes and procedures to ensure conformance is essential Assists in the management of the international registration process for responsible product(s)/product line(s). Prepares Technical Files/Dossiers to support CE marking and ensures they are maintained and periodically updated per procedures. Monitors global regulatory agency regulations for changes and ensures compliance. Manages the process to bring product registration in-house Writes and revises regulatory processes and procedures Demonstrates commitment to the development, implementation and effectiveness of the Quality Management System per ISO, FDA and other regulatory agencies Qualifications: BS/BA in life sciences 2+ years of IVD regulatory experience; 5+ years preferred Strong knowledge of manufacturing quality systems Applying: For immediate and confidential consideration, please email your resume to info@simplybiotech.com or call 858.487.0507 More information can be found at simplybiotech.com

PaxVax

Quality Assurance Manager (5/14/2010) Primary Responsibilities: The QA Manager will be responsible to aid in all QA activities including but not limited to lot release and upkeep and improvements of Quality Systems, and oversight of GMP, GLP, GCP activities as assigned. Specific Responsibilities: Support the design, upkeep, and improvements to the Quality Systems including but not limited to document and process change controls, deviations/CAPAs/ Investigations, materials and lot release process, validations, internal and external audits, simplification/correction of compliance gaps and improvements to the QC systems Support the vendor qualification process to assure quality agreements are established and are in place, vendor qualification program upkeep Support other QA processes such as raw materials and lot release, QC data review, validation efforts, automation activities, and management of ongoing projects as assigned by supervisor Qualifications: Bachelor degree in biology, biochemistry, or a related field Minimum of ten years in a GMP biotechnology or pharmaceutical company environment (in GMP QA and QC of Biologics Products) Thorough knowledge of FDA regulations regarding Quality Systems Ability to work in a fast paced team environment with minimal supervision on multiple projects Excellent written and verbal communication skills Experience in Oral Solid Dosage Products, Vaccines, and LIMS selection/implementation is a plus Apply to: Please email resumes and interest to: hr@paxvax.com PaxVax is an Equal Opportunity Employer and offers competitive compensation and benefits. No relocation assistance is available for this position.

ISTA Pharmaceuticals, Inc.

Regulatory Affairs Specialist IV (5/06/2010) Location: Irvine, California Overall Purpose: The Regulatory Affairs Specialist IV is responsible for providing assistance in supporting the process of meeting requirements established by U.S. governmental agencies in introducing new products to market. This person will also ensure that documents comply with regulatory and company guidance/template specifications. This includes working with all departments to implement and maintain processes and quality control checks to ensure all information provided in the context of regulatory submissions is accurate, complete and meets regulatory document specifications. Primary Responsibilities: Independently plans and prepares submissions for FDA and other international agencies. The incumbent has the lead in developing sections of the U.S. and international submissions Develop regulatory strategies for new products and changes to existing products Identify requirements for FDA regulatory filings, including p-INDs, INDs, NDAs, ANDAs, pre-approval and post-approval reports, etc. Work with ISTA departments in obtaining documentation required for timely FDA filings Review documentation to be filed in regulatory filings to assure ISTA and FDA requirements are met Assures Regulatory Affairs product files are in compliance with regulatory requirements Education & Experience: Bachelors or advanced degree in the science field, such as Chemistry, Biology, Microbiology or equivalent experience Ten years or more in the pharmaceutical industry with direct regulatory experience (including submissions, FDA interactions, etc.) on new drugs (both small and large molecules) and generic drugs including INDs, NDAs (505(b)(1) and 505(b)(2)), ANDAs, post marketing reports, etc. Familiar with current FDA laws, rules, guidance’s, etc. Experience with FDA electronic submissions with strong computer skills is preferred Experience in the Quality Assurance area, including cGMPs, desirable Apply to: Erin Oprian Recruiting Manager ISTA Pharmaceuticals, Inc. 15295 Alton Parkway Irvine, CA 92618 Direct: 949-789-3134 Fax: 949-788-6015 eoprian@istavision.com