Med Tech Regulatory Affairs Specialist — Technical Files

Orthofix Holdings, Inc. in Bussolengo (Verona) is seeking a Technical Product Regulatory Affairs Specialist to join our Regulatory Affairs team as a maternity substitution. You will ensure availability of Technical Documentation File by maintaining EU MDR and FDA submission-ready files and coordinating with Quality Engineering and R&D. The role requires a technical degree and 3+ years in medical devices, strong English, and in-depth knowledge of US FDA CFRs and European MDR.

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