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Principal Regulatory Affairs Specialist

Heartflow· Regulatory Affairs
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Hybrid (San Francisco / Rohnert Park)$188k - $240kFull-timePosted 3w ago

About the role

Regulatory lead for global strategy and submissions of Heartflow AI-driven medical products, focusing on SaMD/AI/ML, mobile apps, and related software-driven health technologies; collaborate with Software Engineering, Data Science, Product Management, Clinical and Quality teams from planning through post-market activities.

Responsibilities

  • Represent Regulatory Affairs on cross-functional Product Development Teams to ensure regulatory alignment and deliverables for submissions.
  • Author and execute global regulatory strategies including FDA Pre-submissions, 510(k)s, De Novo requests, EU MDR CE Marking, and other geographies.
  • Develop submission strategies for advanced digital health technologies, including AI/ML-enabled devices, Good Machine Learning Practice (GMLP), and Predetermined Change Control Plans (PCCPs).
  • Develop relationships and lead interactions with regulatory agencies (e.g., FDA Digital Health Center of Excellence, Notified Bodies) and 3rd party partners for Heartflow devices including algorithm performance evaluation and metrics.
  • Maintain regulatory pre-market and post-market commitments and compliance (registrations, certifications, reporting, special controls, etc); support SOPs and internal guidance; assist in audits and initiatives.
  • Evaluate software changes under FDA and other software change guidance to determine necessary filings versus internal release documentation.
  • Track evolving digital health policies (FDA AI/ML Action Plans, EU AI Act, ISO/IEC standards) and advise internal teams.
  • Provide mentorship and training to software engineers, product managers, and junior regulatory team members on medical device software development and regulations.

Qualifications

  • Bachelor’s Degree in Computer Science (ML/AI), Biomedical Engineering, Software Engineering, Electrical Engineering, or related field.
  • 10+ years of direct Regulatory Affairs experience in medical devices, with at least 4+ years focused on SaMD/SiMD or complex digital health solutions including AI/ML; 6+ years with Master’s or 4+ years with PhD.
  • Direct experience clearing SaMD applications (510(k), De Novo, or CE Mark) with FDA and/or EU Notified Bodies.

Skills

Required:Regulatory strategy and submissionsAI/ML software regulatory knowledge
Nice to have:Regulatory intelligence

Benefits

  • Base salary range $188,000 - $240,000
  • bonus
  • equity
Last updated Oct 5, 2026. Interested? Apply on the company site.

About Heartflow

Decisive Coronary Care

Heartflow’s vision is to transform CAD from the leading cause of death into a disease that can be managed for life.

CCTA ResourcesRoadmap AnalysisFFRCT AnalysisPlaque AnalysisHeartflow OneHeartflow One PlatformMeasurable Impact
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