Senior Regulatory Affairs Lead, AI SaMD
blue venture fundMillbrae (CA)
Senior Regulatory Affairs Lead, AI SaMD
Posted yesterday
blue venture fundMillbrae (CA)
SENIORITY
Manager
About the 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.
Before you apply
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A number in mind
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Your notice period
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