Principal Regulatory Lead - Medical Devices & SaMD

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smartrecruitersPonte Vedra Beach (FL)

Regulatory Affairs Managers Electromedical and Electrotherapeutic Apparatus Manufacturing

SENIORITY

Manager

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About the role

Treace is seeking a Principal Regulatory Affairs Specialist to lead regulatory activities for software devices (SaMD/SiMD) in a fast-growing medical device environment. You will collaborate with Product Development, Quality, Operations, Marketing, and Legal to ensure timely submissions and compliant labeling. The role emphasizes mentorship, process improvement, and staying ahead of regulatory changes. A strong track record in US FDA submissions and international registrations is essential.

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