heartflowMillbrae, CA
Senior Regulatory Affairs Lead for AI/SaMD (Global)
Senior Regulatory Affairs Lead for AI/SaMD (Global)
Senior Regulatory Affairs Lead for AI/SaMD (Global)
heartflowMillbrae, CA
yesterday
Electromedical and Electrotherapeutic Apparatus ManufacturingSurgical and Medical Instrument ManufacturingOther Scientific and Technical Consulting Services
Apply for this 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.
Also on the board Same function, level within a rung
Level
Manager
Location
Millbrae, CA
Occupation
Regulatory Affairs Managers
Industry
Electromedical and Electrotherapeutic Apparatus Manufacturing
Posted
yesterday