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Associate Director/Director, Regulatory Affairs

Associate Director/Director, Regulatory Affairs

Company Name: Longboard Pharmaceuticals Job Location: United States/Remote Position Title: Associate Director/Director, Regulatory Affairs Position Type: Full time General Job Description Working in a team environment, the Associate Director/Director, Regulatory Affairs will be responsible for development of regulatory strategy as well as hands-on management of all technical and operational aspects related to the regulatory lifecycle (e.g., from preclinical candidate designation through registration) of assigned Longboard Pharmaceutical products. Responsibilities: Strategic Planning: Represent the Regulatory Affairs department on multidisciplinary product development teams, develop and implement regulatory strategy for one or more programs, research regulatory precedent related to product class and therapeutic area(s) and assess implications for LP product development/registration, contribute to global product development plans and target product profiles, lead preparation of pediatric investigation plans and rare disease designation applications Operations: Manage all operational aspects of regulatory submissions, including maintaining timelines; organizing submission content; and coordinating the internal/external authoring and review of components of original investigational drug applications, amendments, safety and annual reports, interface with external Regulatory Operations group in the compilation of regulatory submissions in electronic common technical document format, serve as primary liaison for communication with regulatory health authority on assigned programs, prepare team for and lead the conduct of milestone development meetings with regulatory health authority Compliance: Review and communicate current and emerging regulatory requirements for quality, preclinical, and clinical programs to ensure compliance of all development activities with applicable US and international regulations and guidelines, participate in the development and review of standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements, monitor company progress toward fulfillment of regulatory commitments Qualifications: Bachelor’s degree in life sciences required; advanced degree preferred Regulatory Affairs Certification (RAC) a plus Minimum 7 years pharmaceutical Regulatory Affairs experience with focus in development of drugs/biologics Direct experience in preparation, submission and lifecycle management of investigational/marketing applications, including as primary regulatory author Experience negotiating and directly interfacing with US and international regulatory authorities In depth knowledge of GxP/ICH guidelines and regulations Experience in CNS-related therapeutic area and rare disease development a plus Strong written and verbal communication, and ability to communicate regulatory strategy to key stakeholders at all levels of the organization High level of analytical, organizational, and interpersonal skills Ability to work in a dynamic environment with a high degree of flexibility Proven ability to interact effectively across multiple functional groups and projects Ability to travel up to 20% (US and International) Application Information & Contact (How to Apply) Please email your resume to careers@longboardpharma.com Learn more about the company here

IVDR Implementation: Key Considerations Amidst the Looming Deadline

IVDR Implementation: Key Considerations Amidst the Looming Deadline

Register Here Monthly Program event 'co-organized' by SDRAN and OCRA IVDR Implementation: Key Considerations Amidst the Looming Deadline Program Speaker: Gail Gasior, CCRA, RAC, RQAP-GCP Director, Clinical Compliance, Diagnostic Solutions Division Hologic, Inc. & Terrance (TJ) Thiel, RAC Director and Principal Consultant / Consulting Operations Brandwood CKC FLYER Event Agenda: Date: Wednesday, 18 Aug 2021 Time*: 5:30 - 5:40 PM Introductions SDRAN- Sasi Mudumba OCRA-Tommi Papson 5:40 – 6:25 PM TJ Presentation: MDR/IVDR comparison, PERs, and post marketsurveillance 6:25 – 7:10 PM Count-down to implementation, pitfalls and best practices 7:05 – 7:30 PM Q&A, hot topics panel Program Topic: As the IVDR implementation looms closer this program will provide valuable feedback and lessons learned from two thought leaders that are working closing for IVDR certifications. The program will address most recent developments of IVDR, including a status update about notified bodies and implementation deadlines. We will address possible points of confusion between MDR and IVDR as well as share best practices and pitfalls to avoid. Topics will include: Count-down to implementation Guidance and Feedback for Notified Bodies Pitfalls and best practices IVDR to MDR Comparison Performance Evaluation Reports High-Risk Product and Product Batch Release requirements Hot Topics Panel & Q&A at the End Speaker Biography: Gail Gasior, CCRA, RAC, RQAP-GCP Director, Clinical Compliance, Diagnostic Solutions Division, Hologic, Inc. I have 25 years of experience in in-vitro diagnostics clinical trial conduct, design and oversight. The last eleven years I have led the Clinical Compliance function at Hologic (formerly Gen-Probe). I lead the ongoing development and oversight of a robust Clinical Quality Management System to ensure that Clinical Affairs activities are in accordance with company policies and procedures, applicable current laws, regulations and guidelines. I collect and disseminate clinical regulatory intelligence by participating in industry and regulatory working groups and by working with divisional and corporate policy committees. I participate on the AdvaMed Clinical Trial Working Group on topics relevant to IVDs, and the MedTech Europe Clinical Evaluation Working Group. I sat on the ISO Working Group that developed and recently published the new standard ISO 20916, In vitro diagnostic medical devices – Clinical Performance Studies using specimens from human subjects – Good study practice. Terrance (TJ) Thiel, RAC, Director and Principal Consultant / Consulting Operations Brandwood CKC TJ Thiel has worked in quality and regulatory affairs in the Australian, US and European medical device and diagnostics industries for more than 20 years. From major multinationals to small start-ups, TJ has deep experience with global regulatory approvals and registration, providing clients with planning and strategy suitable for both local and world-wide product launches. TJ has prepared, submitted and achieved significant approvals for medical devices – including active implantables (AIMDs), implantables and Software as Medical Device (SaMD) – and in vitro diagnostics including point-of-care, self-testing and laboratory devices. TJ holds Regulatory Affairs Certification (RAC) and has delivered regulatory approvals including FDA 510(k), PMA and De Novo; CE-marking; Health Canada; TGA; PMDA and NMPA. Location: Not applicable - This is an online event Online registration (ends 17Aug2021):

$15 SDRAN Member $15 OCRA Member $20 Non-Member For Questions Email: programs.committee@sdran.org

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Company Name: Invivoscribe Job Location: San Diego, CA Position Title: Senior Regulatory Affairs Specialist Position Type: Full time General Job Description We are looking to add a Senior Regulatory Affairs Specialist will help develop the strategic direction and execute the tactical operational aspects of regulatory compliance and submissions for drug-device combination products. S/he will assure regulatory submission projects are completed on time and that related development files are maintained. Responsibilities: Responsible for generating submissions (Investigational Medicinal Product Dossier (IMPD), New Drug Application (NDA), Investigational New Drug (IND), etc.) to the FDA, NB and ROW agencies. Assess appropriateness of Design Control documents including discovery, CMC and clinical development. Supports IVD projects and submissions. Submits required clinical trial progress reports. Submits required adverse event reports. Submits required annual reports. Provides regulatory guidance to other departments. Qualifications: B.S. degree in Chemistry, Engineering, Biology, or scientifically related field with 5+ years’ experience in a Regulatory department (medical devices or pharmaceuticals.) and 3+ years’ experience with drugs, biologics, and/or combination products. Equivalent combination of education and experience will be considered. Demonstrated experience with all levels of regulatory submissions – IDE/IND, PMA, 510(k), NDA, etc. with knowledge of international regulatory processes preferred. Ability to inform and educate personnel on regulations and policies that impact company’s products and operations. Proficient in Microsoft Office Suite (Word, Outlook, Excel and PowerPoint), and the ability to learn new software programs. Application Information & Contact (How to Apply) Apply here

Manager/Sr. Manager, Regulatory Affairs

Manager/Sr. Manager, Regulatory Affairs

Company Name: Gossamer Bio Job Location: San Diego, CA Position Title: Manager/Sr. Manager, Regulatory Affairs Position Type: Full time General Job Description The Manager/ Sr. Manager, Regulatory Affairs will manage, evaluate, and complete regulatory projects consistent with company goals. The Sr. Manager, Regulatory Affairs will be responsible for tracking regulatory commitments, deliverables and submission content in each region. Responsibilities will span all clinical trials from early stage through NDA/BLA. The Sr. Manager, Regulatory Affairs will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics. Working closely with departmental leadership, the Sr. Manager, Regulatory Affairs will represent Regulatory Affairs on cross-functional project teams, will provide departmentally aligned input to the project team, will lead authoring and preparation of annual reporting, and will manage regulatory submissions and regulatory archive. Responsibilities: Assist in the development and implementation of a global regulatory strategy for assigned projects, along with Global Regulatory Lead(s) and Regulatory CMC. Collaborate with Regulatory Operations to compile and review regulatory submissions for completeness and quality. Ensure that submissions are in conformance with the latest industry and health authority submission standards Assist with logging, tracking and filing of correspondence and submissions to/from regulatory authorities and ensure that no commitment remains outstanding. Identify and draft necessary SOPs and/or Working Practices for Regulatory Affairs. Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions. Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams. Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances, and current industry practice. Qualifications: Manager Level requires Bachelor’s degree in scientific discipline with 7 years pharmaceutical industry experience, including 5+ years in Regulatory Affairs. Sr Manager level requires Bachelor’s degree in scientific discipline with 9 years pharmaceutical industry experience, including 7+ years in Regulatory Affairs. Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical). Experience with CTD/eCTD. Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle. Working knowledge of FDA and ICH regulatory guidance and regulations. Experience of Regulatory Intelligence Management (RIM) or Electronic Document Management System (EDMS) would be an advantage. Strong organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously. Self-motivated, takes ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary. Knowledgeable in industry trends for regulatory affairs. Clinical Study support experience required. Domestic and occasional International travel may be necessary. Application Information & Contact (How to Apply) Apply here

University of Georgia-FDA Regulatory Conference and Workshop

University of Georgia-FDA Regulatory Conference and Workshop

8th Annual Medical Device Regulations Conference September 21-23, 2021 Register Here Medical Device manufacturers, Biodesign Innovators, Regulatory and QA Professionals, and Academics can register now for the 8th Annual UGA/FDA Medical Device Regulations Conference! This conference is co-sponsored by the US Food and Drug Administration and the University of Georgia’s International Biomedical Regulatory Sciences. It will provide educational and networking opportunities to help shape and advance the future of medical device regulatory sciences. Using a tutorial approach, experienced leaders from the FDA, Notified Bodies, the medical device industry, and consulting firms will present and engage the audience on issues related to medical device regulations. The 8th Annual UGA Medical Device Regulations Conference will be held virtually by the University of Georgia College of Pharmacy on September 21-23, 2021. The conference will be of special interest to quality assurance and regulatory affairs professionals working in the medical device industry in the US. The broad range of topics outlined under the Agenda will be presented by highly experienced professionals and technical experts from FDA and medical device industry. Hotel reservations are the responsibility of the individual conferees. Proposed Topics for the conference: FDA Updates: CDRH and ORA Notified Bodies Updates International Updates COVID-19 EUA Lessons Learned Remote Regulatory Assessment Tissue-based Devices Digital Devices

FDA Promotional Materials Submissions in eCTD Format

FDA Promotional Materials Submissions in eCTD Format

Register Here FDA Promotional Materials Submissions in eCTD Format Program Speaker: Rachel Bombara Sr. Regulatory Operations Specialist Certara Synchrogenix FLYER Event Agenda: Date: Wednesday, 21 July 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: This informational presentation will help attendees assess if they’re prepared to submit promotional materials in eCTD format, which is the required format of all promotional materials submissions as of June 24th of this year. It will highlight the background information and basic requirements for these types of submissions. We will also discuss some common errors to avoid and tips for success moving forward. A short question and answer session will follow with participants. This presentation is geared towards entry-level, mid-level, and even experienced regulatory professionals interested in submitting eCTD submissions to CDER OPDP or CBER APLB. Speaker Biography: Rachel Bombara, Sr. Regulatory Operations Specialist, Certara Synchrogenix. She is a seasoned submission lead and publisher with a decade of experience in Regulatory Operations and helping clients achieve their submission goals. From small amendments to large-scale original marketing applications, she has worked with clients on a variety of different submission types, and ensured deliverables to health authorities are timely, of a high quality, and pass technical validation. Preparing promotional material submissions in eCTD and transmitting them via the FDA ESG is a service she regularly provides to clients. Location: Not applicable - This is an online event Online registration (ends 20Jul2021):

$10 SDRAN Member $15 Non-Member For Questions Email: programs.committee@sdran.org

Sr. Lead Regulatory Affairs Specialist

Sr. Lead Regulatory Affairs Specialist

Company Name: Instrumentation Laboratory (Accriva) Job Location: San Diego Position Title: Sr. Lead Regulatory Affairs Specialist Position Type: Full time General Job Description Write Regulatory pre market submissions Responsibilities: Lead in the preparation and submittal of regulatory data required for market clearance, licensing, registration and legalization in both the US and various international markets. Participate in New Product Development cross-functional teams as the RA core team member. Qualifications: Bachelor's degree (Life Science) or equivalent experience preferred. Minimum of eight (8) to ten (10) years of applicable regulatory affairs (RA) experience, preferably within an in-vitro diagnostics environment. Application Information & Contact (How to Apply) Contact Andrea Palumbo-Talent Acquisition at 858-263-2304 or apply on website Learn more about Instrumentation Laboratory (Accriva) here

Regulatory Affairs Publisher - Contractor

Company Name: Animal Cell Therapies Job Location: 11211 Sorrento Valley Road Suite A San Diego, CA 92121 Position Title: Regulatory Affairs Publisher - Contractor Position Type: Contractor Responsibilities: The ideal candidate will be responsible for the overall publication of the submissions including bookmarking and hyperlinking and submission through the eCTD system. Experience in the publication of regulatory fillings is critical. Qualifications:​ Minimum of 3 – 4 year’s experience in Regulatory Affairs publishing and reviewing documents in a pharmaceutical environment, with strong familiarity with the eCTD submission process. Must be highly proficient in Microsoft office, Adobe Acrobat, ISI writer and ISI Toolbox (with proven background in bookmarking and Hyperlink, page stamp, masking and watermarks etc,). Knowledge of eCTD Systems, document scanning, FDA Guidance documents. Must be able to multi-task and work well under tight timeliness. Strong verbal and written communication skills are essential. Application Information & Contact (How to Apply) Email your resume and cover letter to info@actcells.com

Medical Writer

Medical Writer

Company Name: 3D Communications Job Location: Remote Position Title: Medical Writer Position Type: Full time General Job Description 3D Communications provides comprehensive preparation services to pharmaceutical and medical device companies preparing key communications for US and EU regulatory approvals. 3D project teams collaborate with clients to develop clear and compelling scientific narratives in preparation for regulatory submissions, formal FDA and EMA meetings, CHMP oral explanations, and advisory committee meetings. Since 2003, 3D teams have supported more than 350 advisory committee meeting and oral explanation preparations. Medical writers are key members of 3D project teams. Our medical writers develop documents that capture the scientific and clinical history of the product while communicating the messages supporting approval. The medical writer collaborates with the rest of the 3D and client team to align the written materials with the other key project deliverables to drive a successful preparation and ultimately a successful regulatory outcome. Responsibilities: REPORTING: Medical Writers will report to designated project leads for billable activities and will collaborate with the Company Executive Team for non-billable activities. JOB DESCRIPTION: The Medical Writer is responsible for the creation, content development, formatting, editing, review of and/or updates to any document that supports regulatory interactions or meetings (e.g., briefing documents for formal meetings with regulatory agencies, briefing document for CHMP Oral Explanation or SAG, briefing documents for drug/biologic advisory committee or device panel meetings, clinical summary documents for regulatory submissions). The Medical Writer will collaborate with the client to: create a document that aligns with the agreed-upon messages and supporting facts, data, and examples that credibly represent the available data; establish target dates for draft iterations and a final version in line with the agreed-upon contracted services. Each generated or updated version will be supplied in a timely manner to the client for final editing and quality control, as the client is accountable for final content and accuracy. The Medical Writer will perform both Billable and Non-Billable Activities (defined below): Billable Activities: The Employee shall perform agreed upon services for 3D third-party clients in collaboration with other 3D personnel on designated billable activities as set out in executed service contracts (“Billable Activities”). The Billable Activities for this position include, but may not be limited to the following: Establish recommended timeline for iterations and final document based on agreed-upon completion date; Attend kickoff meeting or collaborate with 3D Project team to familiarize with project messages and client project leadership; Provide weekly updates to 3D Project Leads on document development for inclusion in weekly 3D/Client project update calls; Guided by agreed-upon messages, use relevant product CMC, non-clinical, and clinical documents and data (e.g., submission documents, key messages) to develop first draft of document for submission to client and 3D team based on agreed-upon timeline; Using feedback from external experts, 3D colleagues, and client team, develop iterative drafts for each additional test phase meeting for delivery to client, 3D, and relevant external personnel prior to each milestone based upon agreed-upon timeline; o Attend all key meetings to keep notes on document review and feedback; Collaborate with client and 3D team to prepare final version of document for publishing, with references, appendices, and tables for submission to the FDA/EMA in accordance with regulatory timeline requirements. Non-Billable Activities: In addition to Billable Activities, the Employee is expected to periodically participate in activities and services deemed of value to the development of 3D business and service offerings by the 3D Executive Team (“Non-Billable Activities”). These activities include but may not be limited to the following: Proactively look for opportunities with clients to expand a current project or offer new services (e.g., Regulatory, Executive Communications, Value Communications); Draft SOPs for 3D personnel in the performance of medical writing services; Attend and participate in conferences related to 3D service offerings or business development as requested by the Executive Team; Draft and/or edit articles for 3D or third-party publications related to 3D service offerings as requested by the Executive Team; Develop innovative processes, tools, or services for 3D business activities in collaboration with 3D personnel as requested by the Executive Team; Shadow and train designated 3D personnel in the development of medical writing skills necessary for the performance of 3D services. WORK ENVIRONMENT: This position is currently 100% remote during the ongoing COVID-19 pandemic. Under usual operations, occasional travel and performance of Billable Activities at client and third-party sites as required in the performance of 3D services may be required. The position may also require some travel to perform Non-Billable Activities. Total travel time is not anticipated to exceed 10% of overall working time. POSITION TYPE/EXPECTED HOURS OF WORK: This position shall be listed in 3D budgets and service agreements as 3D Medical Writer and shall carry an exempt employment status. It is expected that this position will be a full-time commitment from the Employee, with an average of forty (40) hours per week on combined Billable and Non-Billable Activities. COMPENSATION/BENEFITS: Highly competitive compensation and full benefits including 401K. Qualifications:​ A bachelor’s degree in communications, science, or related field; advanced degree (e.g., MS, PharmD, or PhD) preferred but not required; At least three (3) years of experience acting as the primary author of regulatory and scientific documents (e.g., clinical study reports, FDA meeting documents, NDA/BLA/PMA clinical modules); Expert with Microsoft Office programs, including MS Word, Excel, and PowerPoint, and EndNote; Excellent people skills, with an ability to partner with a dynamic leadership team; Exceptional writing skills are a must; Possesses personal qualities of integrity, credibility, and commitment to corporate mission; Capacity to perform job functions independently in accordance with company process and agreed-upon timelines with some direction by project supervisors; Demonstrated ability to manage multiple writing projects while ensuring excellent quality and timeliness in compliance with budget requirements; can work within a fast-moving environment, while also driving toward clarity and solutions; demonstrated resourcefulness in setting priorities and guiding investment in people and systems. Application Information & Contact (How to Apply) Please send your resume to applications@3dcommunications.us Learn more about 3D Communications here

Health Economics & Reimbursement 101: Dispelling Common Market Access Myths

Health Economics & Reimbursement 101: Dispelling Common Market Access Myths

Register Here Health Economics & Reimbursement 101: Dispelling Common Market Access Myths (US Market / Medical Device Focus) Program Speakers: April Zambelli-Weiner, Ph.D., MPH President and CEO, TTi Health Research & Economics & Avijeet Chopra, Ph.D., MBA HEOR Senior Associate TTi Health Research & Economics Wednesday, June 16, 2021 FLYER Event Agenda: Date: Wednesday, 16 June 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: Obtaining regulatory approval is a hurdle that, once cleared, allows medtech innovators and manufacturers to sell their product, but doesn’t give payers a single reason to cover it. Ensuring that the product or service is utilized to its fullest potential relies on obtaining reimbursement. Payers often require evidence supporting a strong return on investment (in terms of cost savings, lower readmission rates, and improved outcomes) to adopt a new technology and offer reimbursement to providers and patients. While the US reimbursement system is undergoing a transition (transitioning from paying for volume to paying for value), many myths abound with respect to reimbursement and market access for medical technologies. Perpetuating these myths can lead to market failure. In this seminar, these myths will be explored and dispelled, and the importance of health economics in helping clients to develop data-driven solutions and analysis frameworks that articulate their value story in support of coverage, coding and reimbursement (and magnify studies designed to support regulatory approval to serve a dual market access purpose) will be discussed Speaker Biography: Dr. April Zambelli-Weiner is a Hopkins-trained epidemiologist; strategic healthcare leader and innovator; and the President and CEO of TTi Health Research & Economics, located in Westminster, MD. An expert in data creation at every level of the healthcare ecosystem, Dr. Zambelli-Weiner has over two decades of applied experience directing and bringing thought leadership to healthcare projects directly impacting policy and practice. As an accomplished strategic healthcare leader and innovator, Dr. Zambelli-Weiner has helped bring to market and accelerate growth for hundreds of medical technology products including surgical instruments, capital equipment, diagnostics, precision medicine technologies, predictive algorithms and disease management apps, among many others across a wide range of indication areas and use cases. She has authored more than 30 peer-reviewed publications in high-impact academic journals and has presented her research and thought leadership at international conferences, symposiums and workshops, receiving numerous awards. She is a strategic advisor to Federal agencies such as CDC and NIH, serves on numerous medtech advisory boards and is a member of various professional societies and committees, including Healthcare Information and Management Systems Society’s (HIMSS) Public Policy Committee and Health Equity Working Group. She is the founding board member of a new non-profit, PARC, focused on accelerating adoption of pharmacogenomic and precision medicine technologies. Dr. Zambelli-Weiner holds a PhD in Human Genetics & Epidemiology from Johns Hopkins University, an MPH in Epidemiology from Saint Louis University, and a BA in Chemistry and English from Washington & Jefferson College. Avijeet Chopra, Ph.D., MBA is an experienced Global Health Economics and Outcomes Researcher with expertise in health economic modeling, indirect treatment comparisons using meta-analysis, and systematic reviews. He has an extensive background in clinical and translational sciences and analytical research with experience in synthesizing, implementing, and communicating scientific evidence through peer-reviewed publications and user interfaces, in respect to the healthcare landscape and need for pharmaceutical drugs, biotechnology, and medical devices. He serves as HEOR Senior Associate at TTi Health Research & Economics. Avi holds a Ph.D. in Clinical & Translational Sciences from The University of Connecticut and is a Health Economics Fellow from the University of York. Location: Not applicable - This is an online event Online registration (ends 15June2021):

$10 SDRAN Member $15 Non-Member For Questions Email: programs.committee@sdran.org

Regulatory Affairs Specialist II

Regulatory Affairs Specialist II

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

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: programs.committee@sdran.org