Job Description:
Our client is looking for a Senior Regulatory Affairs Specialist for a 12+ month contract. This individual must have at least 8+ years of industry experience and 6+ years focused within EU MDR. This individual will serve as the primary regulatory representative on Product Engineering and Manufacturing teams. The main responsibilities include performing Medical Device Regulations (MDR) regulatory assessments to determine the gaps and impact on design/process/products, technical file updates, creation of Summary Technical Documentation (STED), preparing regulatory submissions, maintaining regulatory filings and licenses, design input/output documentation, identification of applicable standards and guidance documents, and interacting with regulatory agencies as needed. This professional needs to have extensive experience preparing and submitting regulatory filings for the above markets including IDEs, 510(k)s, non-filing justifications, Technical File creation/updates, Canadian License Applications.
Required Experience:
- Regulatory Affairs
- EU MDR
- Gap Assessments
- IDE / 510k Submissions
- Project Management Skills
- STED Template Creation – PLUS
- Regulatory Intelligence exp – PLUS
- Education: B.S. or higher in Engineering or in a science field or equivalent related experience
Remote: Senior Regulatory Affairs Specialist (231387)
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