Regulatory Affairs Manager

Job Description:

We are seeking a highly experienced and motivated Manager, Regulatory Affairs, to join our growing Regulatory Affairs team. This role is critical to ensuring compliance with US regulatory requirements and supporting the development, approval, and lifecycle management of medical devices. The ideal candidate will possess deep expertise in U.S. FDA regulations, and have a good general understanding of EU MDR, and international standards, and will contribute to strategic regulatory planning and execution.

Responsibilities:

• Lead regulatory strategy and submissions for Class II and III medical devices in the U.S.


• Prepare and manage regulatory submissions including 510(k), PMA Supplements, annual reports


• Serve as the US regulatory lead on cross-functional project teams, ensuring alignment with clinical, quality, and R&D functions.
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