The Senior Manager/Associate Director Regulatory Affairs provides regulatory support for multiple diagnostic projects. Supports development and implementation of regulatory strategy for IVDs, including companion diagnostics. Support program efforts relative to premarket submission, diagnostic partnering, FDA interactions and post market regulatory support.
Essential Duties and Responsibilities:
- Ensures early diagnostic regulatory input in early stages and during clinical development to Development Team
- Responsible for generating and delivering documentation for life cycle management and/or registration of products through IDEs, 510(k)s, PMAs, supplements, and technical files for CE marking
- Provides study risk determination for assigned projects within Pharma Business Development activities and potential companion diagnostic projects
- Actively review and edit documents associated with product development activities
- Recognizes potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors
- Assessment of product changes to capture any impact to existing or in-process product registrations and letters to file
- Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements
- Working with Director, Regulatory Affairs, identify risk areas and develop alternative courses of action and development of contingency plans
- Compiles and/or directs the compilation of device master records, technical files, design dossiers, FDA and European submission documents, and/or any other relate documents/reports, ensuring timely submissions to CDRH, etc., to meet Company product(s) and regulatory requirements, and compliance to all approved licenses.
- Monitors worldwide laws and regulations through websites and publications, and identifies and communicates items needed for interpretation for impact to products.
- Assessment of MDR and adverse events for potential regulatory reportabilities. Provide regulatory support as required in the evaluation of customer complaints, ensuring complaint reports meet regulatory requirements.
- Responsibility for ensuring Post Market surveillance/ vigilance systems, liaising with others in the quality departments, QA/QC
- Write and maintain procedures relating to the US and International Regulatory requirements
- Advanced education degree in life-sciences, engineering or public health.
- 6+ years work related profession experience.
- 4+ years experience in drug or diagnostic regulatory affairs.
- 4+ years multi/cross functional leadership experience in regulatory and/or clinical development, preferably in molecular diagnostics
- Experience with IVDs, campanion diagnostics or drug development regulatory requirements
- Track record in successful FDA and global premarket submissions and registrations
- Solid understanding of molecular technologies and the impact on outcomes and diagnostic results
- Leadership capabilities working across varied cultures, expertise and backgrounds
- Excellent negotiation skills on various levels of hierarchy
- Ability to multi-task and shift priorities quickly while working under tight deadlines.