Global Director of Regulatory Affairs, MedTech AI

A leading MedTech company seeks a Director of Regulatory Affairs in Rome, Italy. This role involves leading global regulatory strategy for AI-enabled medical devices, ensuring compliance with FDA and EU regulations, and managing regulatory submissions and post-market surveillance. Candidates should have 8–10 years of experience in Regulatory Affairs, particularly in SaMD, and a strong understanding of regulatory pathways. Leadership skills and a scientific degree are essential. Join us to drive innovation and maintain compliance in a rapidly evolving field.
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