Senior Regulatory Affairs Specialist
About this role
Senior Regulatory Affairs Specialist
We are seeking a Senior Regulatory Affairs Specialist to join Enovis. This role focuses on developing and executing regulatory strategies and managing product submissions for enabling technologies in the orthopedic industry, including hardware and software as a medical device (SaMD).
What You'll Do
- develop and champion regulatory strategies, work within cross-functional teams, liaise with regulatory authorities to support initial launch of medical devices
- manage regulatory activities in the US, EU, and Australia; ensure compliance with TGA, EU MDR, ISO 13485, ISO 14971, 21 CFR 820; support postmarket surveillance and regulatory impact assessments
- develop global regulatory strategies for new product development; lead pre-submission meetings with FDA, Notified Bodies, and TGA as needed
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