Senior Regulatory Affairs Lead for AI/SaMD (Global)

Posted yesterday

heartflowMillbrae (CA)

Regulatory Affairs Managers Electromedical and Electrotherapeutic Apparatus Manufacturing

SENIORITY

Manager

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About the role

Heartflow seeks a Principal Regulatory Affairs Specialist to drive global regulatory strategy for AI-driven medical devices. You will lead regulatory planning, engage with FDA and Notified Bodies, and guide cross‑functional teams through agile development from planning to post‑market clearance. The role emphasizes SaMD and AI/ML governance, software standards knowledge, and mentorship of engineers and product teams.

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