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Sr. Regulatory Affairs Specialist - Cardiac Diagnostics CDx
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Full-time
- Under minimal supervision, the Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations.
- As a Senior Regulatory Affairs Specialist within the Digital Health and Cardiac Diagnostics Regulatory team at Boston Scientific CRM, you will have the opportunity to support bringing state of the art life sustaining and life-saving technologies to patients worldwide.
- Coordinates, compiles, and submits U.S. and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR
- Supports requests from BSC International Regulatory related to submissions, registrations, and change assessment
- A minimum of 5 years work experience in regulatory affairs or related discipline (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in medical devices, pharmaceutical, or health care industry
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