blue venture fundMillbrae, CA
Senior Regulatory Affairs Lead, AI SaMD
Senior Regulatory Affairs Lead, AI SaMD
Senior Regulatory Affairs Lead, AI SaMD
blue venture fundMillbrae, CA
today
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 lead global regulatory strategy and submissions for its AI-enabled medical devices. You will collaborate with software, data science, product, and quality teams to secure timely market clearances. You will drive regulatory intelligence, manage software change impact analyses, and liaise with regulators and Notified Bodies to enable approvals, requiring strong AI/ML software regulatory background.
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
today