Sr. Regulatory Affairs Specialist (Hybrid - Acton, MA)
About this role
About the Role The Senior Regulatory Affairs Specialist will lead activities supporting domestic and international regulatory registrations and submissions for medical devices. The role involves collaboration with Marketing, New Product Development, Manufacturing and Engineering to ensure timely approvals and ongoing compliance across markets. What You'll Do
- Support regulatory approvals for medical devices in domestic and international markets, including pre-market, post-market and physician-initiated studies.
- Provide regulatory support to product development, manufacturing, and clinical studies; support ongoing compliance and corporate initiatives.
- Partner with Marketing and Development teams to review labeling, promotional materials, product changes, and documentation requiring government approval.
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