Regulatory Affairs Specialist III

Boston Scientific is seeking a Regulatory Affairs Specialist III to support the development of domestic and international strategies for regulatory approval of Class I, II, and III medical devices. The ideal candidate will have a bachelor's degree and at least 3 years of experience in Regulatory Affairs or a related discipline within medical devices.

Requirements

• Support the development of domestic and international strategies for regulatory approval of Class I, II, and III medical devices.
• Represent Regulatory Affairs on cross-functional projects, including product development, manufacturing process changes, and continuous improvement efforts.
• Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations.
• Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR.
• Support international regions to gain and maintain product approvals.
• Contribute to continuous improvement of departmental and divisional quality through collaboration, best practices, and knowledge sharing.
• Support regulatory audits, as required.

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Tuition Reimbursement
• Relocation Assistance