May Event: FDA Novel Device Programs:Breakthrough Device Designations and Safer Technologies Program
Register Here FDA Novel Device Programs: Breakthrough Device Designations and Safer Technologies Program (STeP) Program Speakers: Kathy Herzog Regulatory Consultant DuVal & Associates, PA & Lisa Pritchard Regulatory, Quality & Compliance Consultant DuVal & Associates, PA Wednesday, May 19, 2021 FLYER Event Agenda: Date: Wednesday, 19 May 2021 Time*: 5:30 - 6:00 PM Virtual Networking 6:00 – 6:05 PM Welcome and Announcements 6:05 – 7:05 PM Program Presentation 7:05 – 7:30 PM Q & A
*Times are approximate. Program Topic: FDA Novel Device Programs: Breakthrough Device Designations and Safer Technologies Program (STeP) Getting Your Product Ready for the Red Carpet Heads turn and crowds make way for VIPs as they make their way down the red carpet. What if your medical device could receive this same treatment? The FDA novel device programs (Breakthrough Device Designation program and STeP) are ways to roll out the red carpet for a device to achieve commercialization. This discussion will provide insights to help you understand the FDA Breakthrough Device Designation and Safer Technologies Program (STeP) and determine whether one of these designations should be considered as part of your device development program. DuVal & Associates will share experiences and best practices to help you successfully navigate the process for these novel device programs to accelerate commercialization of your product that is worthy of VIP status. In this program, we will cover the following topics Foundations and history of novel device programs Breakthrough Device and Safer Technologies Criteria How to complete your request Maximizing benefits Best Practices Q&A Speaker Biography: Kathy Herzog, BSME, is a Regulatory Consultant at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. She has worked in the medical device industry for 35 years, primarily in the areas of product design and development, regulatory, and project/program management activities for class III products in the urological, neuromodulation, drug delivery and pain control therapeutic areas. Prior to joining DuVal & Associates, Kathy worked 26 years at Medtronic in various roles and responsibilities including regulatory strategy planning for US, EU, CAN, and AU submissions (i.e., IDEs, original PMA, PMA supplements, FDA advisory panel meetings, and design dossiers for CE Mark), labeling development, promotional copy review, off-label information management, risk assessment, adverse event reporting, call center management, business process improvement, quality system compliance, SOP development, compliance training, Medical Affairs, and multiple local and global project and program management activities. Kathy earned a Bachelor of Science in Mechanical Engineering from the University of Wisconsin-Platteville. She has a Green Belt certificate in Lean Six Sigma. Lisa Pritchard, BSEEE, is a Regulatory, Quality & Compliance Consultant at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. She focuses on advising clients on Regulatory, Quality and Compliance topics. Lisa works extensively assisting clients with worldwide regulatory strategies, marketing submissions and applications (FDA submissions such as pre-submissions, IDEs, breakthrough Device Designations, 510(k)s, De Novos, PMAs, Emergency Use Authorizations, and advisory panel meeting preparation; European Design Dossiers, Technical Files, and Clinical Evaluation Plans and Reports; Canadian license applications; and Australian listing applications); quality system strategies, SOP development and review, and compliance topics. Lisa brings over 30 years of experience in working with industry. Prior to joining DuVal & Associates, she executed successful Regulatory, Quality and Compliance strategies at a variety of device companies including American Medical Systems, Medtronic, Uromedica, and EnteroMedics. She brings extensive experience in strategy development, submission preparation, regulatory body negotiations, advertising/promotional materials assessment, inspection/audit preparation and conduct, quality system design, risk assessment, development of design control documentation, usability evaluations, clinical trial design, and adverse event reporting. Lisa earned her Bachelor of Science, Electrical and Electronics Engineering, from North Dakota State University. Location: Not applicable - This is an online event Online registration (ends 18May2021):
$10 SDRAN Member $15 Non-Member For Questions Email:
Company Name: Grifols Diagnostic Solutions Inc. Job Location: San Diego, CA Position Title: Regulatory Affairs Specialist II Position Type: Full time Overview of Position Regulatory Affairs Specialist 2 responsible for domestic and international regulatory activities associated with FDA, Notified Body in EU, and other international regulatory agencies. This position requires a person with commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting. Responsibilities: Prepare, compile and publish electronic pre-market and post-market regulatory submissions for FDA (CBER) including IND, BLA, Prior Approval Supplement, CBE/CBE-30 supplement, annual Report and Type B/C Meeting Requests. Compile Technical Files and Design Dossiers for IVD medical devices to support EU CE-Mark. Interact with business partners to support ROW submissions for IVD medical devices (Asia PAC, Mexico, Brazil, Canada etc.). Interact with FDA, write responses to information requests, compile complete response letters. Participate in the preparation of 510(k), PMA and PMA Supplement submissions for FDA (CDRH). Develop and execute submission strategies for assigned projects. Monitor progress on key project deliverables and provide status updates on regular basis. Review of product labeling, literature and Web site for accuracy, consistency and regulatory compliance. Develop and/or revise regulatory procedures. Provide regulatory support to existing and new cross-functional product core teams. Review new product design protocols related to verification and validation, risk assessment, etc. Education Demonstrated ability to coordinate complex projects. Strong oral and written communication and presentation skills Solid working knowledge of the US Regulations and European IVD and medical device directives Good analytical and problem solving skills. Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices. Experience with (US) Biologics and IVDs highly desirable. Capacity to communicate regulations to technical functions within the company. Ability to manage relationships with FDA and international customers (e.g., regulatory agencies, distributors, etc.) Solid computer skills in Microsoft Office. Qualifications: Bachelor's Degree required in the life sciences or engineering with a minimum of 5-8 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics Industry. Master’s Degree and/or RAC preferred with a minimum of 3-5 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics Industry. Experience Application Information & Contact (How to Apply) Please apply by visiting here Learn more about Grifols here
April Event: The FDA Medical Device Development Tool (MDDT) Program
Register Here The FDA Medical Device Development Tool (MDDT) Program: An Opportunity to Qualify Innovative Test Methods for Regulatory Use Program Speaker: Ron Brown Risk Science Consortium, LLC Wednesday, April 21, 2021 FLYER Event Agenda: Date: Wednesday, 21 April 2021 Time*: 5:30 - 6:00 PM Virtual Networking 6:00 – 6:05 PM Welcome and Announcements 6:05 – 7:05 PM Program Presentation 7:05 – 7:30 PM Q & A
*Times are approximate. Program Topic: Biocompatibility testing of medical devices is undergoing an exciting evolution; transitioning from a process that largely relied on the results of animal testing to one that increasingly involves the use of New Approach Methods (NAMs), like in vitro methods and computational models, for the biological safety assessment of devices. In this presentation, we will discuss the current regulatory environment regarding the acceptance of NAMs as part of a biological evaluation strategy for medical devices and we will explore how the FDA Medical Device Development Tool (MDDT) Program can be used as a means to qualify NAMs for regulatory use. Ron will provide practical advice for developers of innovative new assays or software who may want to qualify their tools for regulatory use through the MDDT program and will also share some thoughts on how the increased regulatory acceptance of NAMs may shape the future of biocompatibility testing. Speaker Biography: Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis. Location: Not applicable - This is an online event Online registration (ends 20Apr2021):
$10 SDRAN Member $15 Non-Member For Questions Email:
Company Name: Equillium, Inc. Job Location: San Diego, CA Position Title: Director Regulatory Affairs Position Type: Full time Overview of Position The Regulatory Affairs Director serves as the Regulatory Lead for development projects while managing, reviewing, planning and preparing complex regulatory submission documents for global regulatory filings. Among other responsibilities, the Director will interpret regulations, and provide regulatory guidance to project teams. The Director drives regulatory strategy, advising on CMC, non-clinical and clinical development programs for assigned projects in line with business goals and objectives as well as provides regulatory affairs perspective to project teams and other functions. Lastly, the Director supports management with development and implementation of departmental strategies and policies. Responsibilities: Represent regulatory in cross-functional teams and provide functional teams with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development and registration. Develop and execute regulatory strategies to ensure (nonclinical, clinical, CMC) development plans are comprehensive and comply with regulatory requirements for marketing applications. Coordinate the preparation, review and execution of regulatory submissions (e.g., IND, IND amendments, CTA/IMPD, annual report, briefing document, iPSP/PIP, safety reports, marketing applications). Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained. Effectively plan, organize, and conduct formal meetings with regulatory agencies. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications. Maintain knowledge of the regulatory landscape to pro-actively assess impact of changes on the development programs. Interact and manage external vendors and proactively resolve issues related to outsourced regulatory activities. Responsible for communication of submissions and approvals to relevant cross functional teams. Ensure archiving of regulatory documents (eg, submissions, internal memos, key correspondence). Plan, develop and write Standard Operating Procedures (SOP) to support the Regulatory Department activities. Interact with Company personnel to implement SOPs. Provide input into critical metrics and management reports. Proactively seeks out and recommends process improvements. Other regulatory activities as assigned. Job Qualifications: Ability to understand scientific and health principles related to product development and regulations. Attention to detail. Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment. Experience in successfully managing the operations of domestic and international clinical trials. Proven ability to manage multiple tasks and associated deadlines. Exceptional communication (oral and written) and interpersonal skills. Strong computer literacy, including Microsoft Office suite. Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment. Education and Experience Bachelor’s degree in scientific discipline is required. A Master’s degree in a scientific discipline or regulatory and/or law discipline or J.D. is highly desirable. 10 years of regulatory experience; OR a Master’s degree, or JD with a minimum of 7 years of regulatory experience in regulatory strategy development. Managing and coordinating regulatory submissions (IND, NDA/BLA, amendments, supplements, annual reports, etc). Preparation and coordination of CTA submissions. Experience in biologics is a plus. Application Information & Contact (How to Apply) Please apply by visiting the job portal. Email resume to Learn more about Equillium, Inc. here.
March Event: A Window into the Changing Landscape of FDA Drug Effectiveness Standards
Register Here A Window into the Changing Landscape of FDA Drug Effectiveness Standards Program Speaker: Frank Sasinowski Director at Hyman, Phelps & McNamara, P.C. Wednesday, March 17, 2021 FLYER Event Agenda: Date: Wednesday, 17 March 2021 Time*: 6:00 – 6:05 PM Welcome and Announcements 6:05 – 7:05 PM Program Presentation 7:05 – 7:30 PM Q & A
*Times are approximate. Program Topic: Almost 60 years have passed since the requirements for efficacy were first added to the Federal Food, Drug, and Cosmetic Act with the Kefauver-Harris Amendments in 1962. Following that landmark addition to require evidence of efficacy for drug approval and marketing, what constitutes substantial evidence of effectiveness has continually evolved. These changes have been driven by numerous forces such as new statutory revisions, long overdue incorporation of the patient voice in regulatory decision-making, responses to the unique opportunities of drug discovery in the 21st Century as well as the hurdles of rare diseases and the need to quickly manage public health emergencies like Covid. FDA response to these forces comes in cycles, whereby every 20-25 years the Agency revisits and updates the drug effectiveness standards. Frank Sasinowski will draw upon his nearly 40 years of drug development experience to illuminate how the FDA appears to be on the cusp of another major revision. His talk will point to some of this history, examine the current signals of change coming from the FDA, and, most importantly, illuminate these signals by looking to his personal and recent experiences assisting pharmaceutical clients across the full spectrum of diseases and drug modalities. Speaker Biography: Frank J. Sasinowski, M.S., M.P.H., J.D., joined FDA in 1983 as regulatory counsel in the Center for Drugs and Biologics, where he was key to implementing both the 1983 Orphan Drug law and the 1984 Hatch-Waxman law. In 1987, he left the FDA as Deputy Director of health policy in Commissioner’s office and joined Hyman, Phelps & McNamara. Frank was involved in 6 of the most recent 8 drugs FDA approved by way of its accelerated approval process. He has helped secure FDA approval for hundreds of new drugs, including more than 100 new molecular entities, often for serious and rare diseases by assisting sponsors and patient organizations in developing new medicines. Frank is involved in many cell and gene therapies and aided significantly on the first approved systemic gene therapy, Zolgensma. In its March 2012 issue, the Drug Information Journal published Frank’s seminal analysis on therapies for rare disorders: “Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs: Cataloguing FDA’s Flexibility in Regulating Therapies for Persons with Rare Disorders.” Other papers of his on Accelerated Approval and Orphan Drugs are regularly cited by FDA, industry and academia as well. Thanks to his extensive FDA experience, both from within the Agency & from a sponsor’s perspective, as well as his passionate advocacy for integrating the voice of the patient in developing medicines, Frank possesses a nuanced & deep understanding of the drug regulatory process. Since 2014, Frank has been an Adjunct Professor of Neurology at the University Of Rochester School Of Medicine. His work has been widely recognized by industry and political leaders. For example, Frank was asked by both political parties to testify at the May 2014 inaugural congressional hearing on the 21st Century Cures law. In August 2018 Frank was appointed to the Board of Directors for the Alliance for Regenerative Medicine (ARM) Foundation for Cell and Gene Medicine. In May 2013, the National Organization for Rare Disorders (NORD) awarded Frank its first ever Lifetime Achievement Award. In 2000, Frank was elected to NORD’s Board of Directors, where he served as Chair and as Vice Chair & was on its Board until 2016. In 2017 Frank joined the Board of the Everylife Foundation for Rare Diseases where he currently is its Vice Chair. In October 2012, President Obama recognized Frank’s contributions to the President’s Council of Advisors on Science and Technology (PCAST) report, “Propelling Innovation in Drug Discovery, Development and Evaluation.” Frank is a founding Board member of the IndoUSrare patient organization, representing those in India and in the US with rare conditions. Frank has also served on the Board of Directors of the United States Pharmacopeia (USP) and has served on the board of several biotechnology companies. Location: Not applicable - This is an online event Online registration (ends 16Mar2021):
$10 SDRAN Member $10 Non-Member For Questions Email:
Company Name: Henry Schein Orthodontics Job Location: Carlsbad, CA Position Title: Regulatory Affairs Specialist Position Type: Full time Responsibilities: · Prepare and submit registration dossiers to ensure compliance with the FDA, Health Canada, EU Competent Authorities, etc., for timely registration approvals. · Create, review and maintain CE Technical Files and make appropriate submittals to the EU Representative and Notified Body to ensure compliance with the Medical Device Directive and Medical Device regulation. · Provide guidance, review and approval of promotional and advertising materials, product claims, training materials, Instructions for Use, labels and other related labeling to ensure compliance with regulations. · Assist with post market surveillance activities, i.e., adverse event reporting and field corrective actions. · Create, maintain and ensure accuracy of regulatory documentation, including but not limited to: 1) MAUDE Post Market Surveillance and 2) CER's for branded products at required intervals. · Represent RA in New Product Meetings to establish regulatory strategy, classification, hazard class and regulatory applications, as required. · Review and implement change requests and notifications as they impact regulatory documentation. · Work cross functionally to ensure timely submission of international requests. · Participate in meetings with regulatory agencies when required. · Support the preparation of Audit documentation when required. · Assist in authoring department reports to ensure internal metrics are met. · Stay current on applicable FDA, ISO (including risk management) and other applicable industry requirements. · Participate in special projects and performs other duties as required. Qualifications: · Ability to effectively problem solve through critical thinking and root cause analysis with · Minimal direction and make decisions with confidence · Excellent organizational skills and attention to detail · Excellent written and verbal communication skills to include interacting with both internal personnel and external organizations (regulatory authorities, customers, distributors, etc.) · Ability to prioritize, multitask and adapt to change · Ability to work within budget constraints and to work with minimal guidance to perform job function · Ability to respond in a timely manner to inquiries and complaints from regulatory agencies · Word processing skills, including Microsoft Word, Excel, and PowerPoint Education and Experience ·Four-year degree in sciences or health related field with 2-4 years related experience; OR 5 -7 years prior experience as a Regulatory Affairs Specialist in a medical device regulated facility. · Hands on experience with international registrations a must, preferably in the dental device industry. Application Information & Contact (How to Apply) Please apply by visiting the job portal and searching for 'regulatory affairs' in the keywords section. Learn more about Henry Schein Orthodontics here.
Company Name: Turning Point Therapeutics Job Location: San Diego, CA Position Title: Associate Director/Senior Manager, Regulatory CMC Position Type: Full time Responsibilities: Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead program, Repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer (NSCLC) and advanced solid tumors. Turning Point Therapeutics is driven to develop therapies that mark a turning point for patients in their cancer treatment. Turning Point Therapeutics is seeking an Associate Director/ Senior Manager of Regulatory CMC. The position is responsible for working in a fast-growing, highly dynamic biotechnology environment, closely interacting with our in-house Regulatory Group and CMC Operations and Quality teams as well as external experts and strategic partners. The position will provide regulatory support for assigned corporate development programs and is responsible for the regulatory aspects of the Chemistry Manufacturing Controls (CMC) development for small molecules. The position will participate in global CMC regulatory activities as necessary to conduct clinical trials and achieve marketing approval of drug candidates. Serves as a resource to the CMC team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through marketing application. This position will report to the Director of Regulatory CMC. · Supports the CMC regulatory affairs activities for compounds in development in line with US, European, International Conference on Harmonization (ICH), and other applicable requirements. · Coordinates with Regulatory, Quality Assurance, Pharmaceutical Development, and other functional areas to develop and implement CMC regulatory strategy. · Supports the regulatory function on assigned development teams providing CMC regulatory guidance and strategy including identifying and assessing regulatory risks. · Collecting documentation from other line functions to support submission preparation. · Manages the timely preparation, review, and submission of documents to regulatory authorities including FDA, European Medicines Agency (EMA), and other national authorities, to support the conduct of clinical trials and marketing applications. · Ensures compliance of CMC activities with applicable regulatory requirements. · Evaluates manufacturing processes and changes, assesses the regulatory implications, and support their implementation. · Maintains current knowledge of the relevant guidelines and regulations and determine applicability to company activities. · Other duties as assigned. Requirements: · A minimum of a Bachelor’s degree in life science (e.g. Chemistry, Pharmaceutics, Biochemistry, Biotechnology, Biology) or equivalent. · Knowledge and understanding of US as well as global regulatory regulations and guidelines. · Previous experience in authoring CMC components (Module 3) of Investigational New Drug (IND) Applications, IMPD’s for ex-US submissions. Experience in authoring New Drug Application (NDA)/Marketing Authorization Applications (MAAs) preferred. · Ability to work in a cross-functional team environment and manage competing priorities. · Strong interpersonal skill, attention to detail, and excellent organizational, computer, and documentation. Ability to meet deadlines and perform multiple tasks in a fast-paced setting. · Demonstrated personal initiative, responsibility, flexibility, the ability to work under limited supervision, and the ability to handle multiple project assignments. · 5+ years in regulatory CMC in biopharmaceuticals preferred. · Working knowledge of chemistry/biotechnology, analytics, or pharmaceutical technology. · Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines. · Knowledge/experience of regulations, guidelines for NCEs, and product lifecycle maintenance desirable. · Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload. · Effective planning, organizational and interpersonal skills. · Reasonable approach to risk assessment. · Excellent written/spoken communication and negotiation skills. Computer literacy. Education and Experience · Bachelor's degree in life science or an equivalent combination of relevant education and applicable job experience may be considered. · Additional consideration is given for applicants with an advanced degree in chemistry (PhD). · A minimum of 6 years progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development. · Level will depend on education and experience. Application Information & Contact (How to Apply) Please apply here. Learn more about Turning Point Therapeutics here.
Register Here Join us for an evening of networking and fun on Zoom breakout sessions Wednesday, February 17, 2021 FLYER Event Agenda: Date: Wednesday, 17 Feb 2021 Time*: 6:00 – 7:30 PM PST
*Times are approximate. Program Topic: · Opportunity Drawing with the chance to win SDRAN membership, monthly programs & RAC classes for 2021 · Get to know the SDRAN committees and board members · Network with other SDRAN members · Ask Me Anything (AMA) with our regulatory experts in Pharma & Med Device · Talk to Admissions reps from SoCal to see if a MS in Regulatory is right for you. Location: Not applicable - This is an online event Online registration (ends 16Feb2021):
FREE SDRAN Member $10 Non-Member For Questions Email:
January Event: 2021 Annual Meeting and January Program
Register Here Join us for a brief 2020 SDRAN recap followed by a presentation entitled: FDA Feedback from Recent Biocompatibility Submissions Wednesday, January 20, 2021 FLYER Event Agenda: Date: Wednesday, 20 January 2021 Time*: 6:00 – 6.05 PM – Welcome - Erica Livingston & Sasi Mudumba 6:05 – 6.30 PM – Annual Meeting 6:30 – 7.30 PM – Program Presentation 7:30 – 7:45 PM – Q & A
*Times are approximate. Speaker: Thor S. Rollins Director, Toxicology and E&L Consulting Nelson Laboratories, LLC Program Topic: Nelson Labs has a great deal of experience performing biocompatibility and extractable and leachable (E&L) studies for regulatory submissions - including the US FDA. With this experience, Nelson Labs has followed FDA feedback trends on recent submissions and developed specific procedures to address this feedback. In this presentation, Thor will cover the recent FDA biocompatibility and E&L feedback and concerns and will discuss approaches to address these concerns before the submission process. Speaker Biography: Thor Rollins is a certified microbiologist who specializes in the selection and execution of in vitro and in vivo biocompatibility tests. Currently he is the Director, Toxicology and E&L Consulting at Nelson Laboratories, LLC. He actively speaks on biocompatibility related topics through external seminars, webinars, conferences, and trade shows. Thor has published multiple peer-reviewed articles and white papers regarding the proper testing of medical devices. Thor is a participating member of all AAMI (Association for Advancement of Medical Instrumentation) TC 194 and ISO 10993 committees. He plays an active role with the FDA and other regulatory committees in developing standards concerning biocompatibility methods; he is also a voting member regarding changes to those standards. As one of a select group of experts in the industry, Thor's participation on these committees offers him unique insight into industry changes which he uses to help prepare clients for changes in testing. Location: Not applicable - This is an online event Online registration (ends 19Jan2021):
$10 SDRAN Member $15 Non-Member For Questions Email:
Company Name: Hologic Job Location: San Diego, CA Position Title: Senior Clinical Compliance Specialist Position Type: Full time Responsibilities: • Maintains and contributes to a Clinical Quality Management System to ensure San Diego Clinical Affairs (CA) activities are carried out in accordance with current applicable company policies and procedures, and laws, regulations, and guidelines • Researches and summarizes knowledge and information on current regulations, guidance, best practices relevant to Hologic Diagnostic products and clinical studies; publishes and presents assessments and findings to stakeholders • Hosts internal Quality Assurance (QA) audits of CA, and supports audits and inspections of Hologic conducted by external regulatory entities (e.g., US FDA Bioresearch Monitoring (BIMO), Notified Bodies (NB)) • Conducts audits of clinical studies at external sites and in-house • Conducts review and change control of CA documents and procedures in the Quality System Manual and in department-specific libraries • Oversees and manages CA department and corporate policy and procedure training requirements • Supports CA personnel on use of corporate and department systems used for creating, editing and storing documents and information; curates documents and information to ensure relevancy and contemporaneousness • Provides support to clinical study projects and functions as needed • Keep current in IVD Clinical, Regulatory and Quality trends and intelligence by conducting relevant research online and by attending forums. Write summaries to provide relevant information to stakeholders as requested. Share and curate relevant information on CA Intranet • Support CA as a subject matter expert (SME) in audits of CA by meeting with auditors and providing documentation and information • Conduct periodic audits of Trial Master Files (TMFs) in-house; audit external clinical study sites as assigned by study management. Write detailed reports and communicate findings • Conduct change control activities for all Clinical Affairs documents in Agile Product Lifecycle Management (PLM) environment, and in the SharePoint Clinical Documents library • Champion department and corporate training for Clinical Affairs; ensure department and corporate training requirements are kept current; identify gaps. Act as department Superuser of corporate training system Qualifications: • Strong knowledge of US and EU regulations relevant to Medical Device and IVD clinical trials and Quality Systems, including GCP • Excellent technical writing and presentation skills • Advanced user of Microsoft Office (Word, Excel, PowerPoint) and Visio a plus; experience using Microsoft SharePoint a plus • Education • Minimum BA/BS degree in Life Sciences or equivalent qualification • Advanced degree or professional certification in Clinical, Regulatory and/or Quality (e.g., RAC, CCRA/CCRP, RQAP-GCP) is highly preferred Education and Experience • 8-10 years of progressive experience in clinical research within a regulated industrial setting. Experience in an IVD environment is highly preferred • Reading, interpreting, and summarizing regulations, guidelines, best practices relevant to clinical research • Writing and editing summary documents, procedures, protocols, or other technical documents, and presenting to stakeholders at all levels • Hosting audits and conducting in-house and external site audits. GCP audit experience preferred • Experience auditing documents and processes • Use of change management concepts and software, and Microsoft Office tools Application Information & Contact (How to Apply) Please apply here. Learn more about Hologic here.
Company Name: ICUmedical Job Location: San Diego, CA Position Title: Senior Associate, Regulatory Affairs - Device Position Type: Full time General Job Description: Provides regulatory support and expertise associated with global and US registration of device products (safety software portfolio), including in-depth analysis of the requirements and tracking of deliverables. With oversight, supports creation of global regulatory strategies and assists in execution including creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change management. Responsibilities: Provides regulatory advice and support to assigned products/teams. Identifies and communicates registration needs and strategies. Maintains awareness of applicable regulations. Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines. With oversight, serves as a liaison with regulatory agencies pertaining to assigned products. Assists in the preparation of agency meeting packages and strategies for agency meetings. Evaluates manufacturing and labeling changes for regulatory impact with guidance. Accurately describes these changes for ease of regulatory agency review. Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review. Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team. Qualifications: Review and approve critical documents, seeking guidance when necessary. Review technical reports and determine acceptability for regulatory submission. Identify registration documentation deficiencies and work with colleagues to accomplish resolution. Interpret global regulations and assure regulatory compliance, minimizing development costs and cycles. Define and negotiate regulatory strategy with supervision. Exercise good judgment within policy and regulations. Responsible for tracking and completion of assigned registration activities. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters. Follows scientific arguments, identifies regulatory scientific data needs and with supervision solves regulatory issues. Presents scientific data effectively orally and in writing in a logical and persuasive manner. Provides daily regulatory support to new product development teams and commercial support with guidance. Participates in preparing regulatory strategies. Reviews submissions, regulatory commitments, strategy decisions, and changes to resource allocations with manager prior to execution. Acts independently on all routine issues, makes judgment and executes. Education and Experience Bachelor’s Degree preferred in pharmacy, biology, chemistry, pharmacology, engineering or related subject. Master’s Degree or P.H.D preferred RAC Certification preferred Minimum of 3 years of experience in Regulatory Affairs, Research, Development or related area. Able to follow scientific arguments. Good interpersonal skills. Good oral and written communications skills. Developing negotiating skills. Developing understanding of business needs. Minimum Qualifications Must be at least 18 years of age Must pass pre-employment drug screen and background check Travel Requirements Typically requires travel 5-20% of the time Physical Requirements and Work Environment This is largely a sedentary role. This job operates in a professional office environment and routinely uses standard office equipment. Work is performed in a clean room environment While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the machine they are operating Operator is required to use computer or touch screen to enter work order data Must be able to occasionally move and lift objects of up to 25 lbs We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity. Application Information & Contact (How to Apply) Please apply here. Learn more about ICUMedical here.
Register Here Member Appreciation Event: CSI MURDER MYSTERY Wednesday, December 02, 2020 FLYER Event Agenda: Date: Wednesday, 02 December 2020 Time*: 6:00 – 8:00 PM Member Appreciate Event (ONLINE)
*Times are approximate. For a special member appreciation event this year, please join us on Wednesday, 02 December 2020 at 6:00pm for a night of fun with our virtual CSI murder mystery team building experience! For 2 hours, be part of a Crime Investigation team and attempt to solve a double homicide. You will be teaming up with a CSI expert and conducting suspect interrogations, working with recreations of murders and events, and an off-site crime scene evidence lab. Will you have what it takes to solve this murder? Please make your reservation early for this annual Members Only event! Registration is capped at 100. Location: Not applicable - This is an online event Online registration (ends 28Nov2020):