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Senior Regulatory Affairs Lead, AI SaMD

Job in San Francisco, San Francisco County, California, 94199, USA
Listing for: The Blue Venture Fund
Full Time position
Listed on 2026-10-09
Job specializations:
  • Science
    Healthcare Compliance, Data Scientist
Salary/Wage Range or Industry Benchmark: 188000 - 240000 USD Yearly USD 188000.00 240000.00 YEAR
Job Description & How to Apply Below

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.

We would love to welcome a new Senior Regulatory Affairs Lead, AI SaMD to our group in San Francisco, CA, United States.

This is an excellent position to take on the Senior Regulatory Affairs Lead, AI SaMD role at The Blue Venture Fund.

As a Senior Regulatory Affairs Lead, AI SaMD, you will play an important part at The Blue Venture Fund in San Francisco, CA, United States.

Position Requirements
10+ Years work experience
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