Heartflow
Principal Regulatory Affairs Specialist
San Francisco, California; Rohnert Park, California · Principal
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Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
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DOL prevailing wage, 2026-27 wage year · Compliance Officers (13-1041) · San Francisco-Oakland-Fremont, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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About the role
- Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology.
- Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.
- In this role, you will serve as a regulatory subject matter expert across SaMD, artificial intelligence/machine learning (AI/ML) algorithms, mobile medical apps, and other products.
Responsibilities
- Quality System Support: Maintain regulatory pre-market and post-market commitments and compliance (establishment registrations, certifications, reporting, special controls, etc) and related activities.
- Support development of SOPs and internal guidance.
- Support Quality organization as necessary in audits and initiatives.
- You will partner closely with Software Engineering, Data Science, Product Management, Clinical and Quality teams from initial agile planning through global commercial clearance and post-market regulatory activities.
Requirements
- Bachelor's Degree in Computer Science (ML/AI), Biomedical Engineering, Software Engineering, Electrical Engineering, or a related scientific field.
- 6+ years and a Master's degree
- or 4+ years with a PhD.
- Knowledge of software-specific standards and frameworks:
- Proven track record working effectively within software development environments.
Nice to have
- Direct experience submitting Predetermined Change Control Plans (PCCPs) for AI/ML algorithms.
- Heartflow is an Equal Opportunity Employer.
- This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.
- Positions posted for Heartflow are not intended for or open to third party recruiters / agencies.
- Submission of any unsolicited resumes for these positions will be considered to be free referrals.
Compensation
- This position has an estimated base salary of $$188,000 - $240,000, bonus, and equity. #LI-IB1
Benefits
- We are seeking a Principal Regulatory Affairs Specialist to drive global regulatory strategy and submissions for our AI-driven Heartflow medical products.
- Advanced Technology Filings: Develop submission strategies for advanced digital health technologies, including AI/ML-enabled devices, Good Machine Learning Practice (GMLP), and Predetermined Change Control Plans (PCCPs).
- Leadership & Digital Health Intelligence
- Regulatory Intelligence: Track evolving digital health policies (e.g., FDA AI/ML Action Plans, EU Artificial Intelligence Act, ISO/IEC standards) and provide guidance to internal teams.
- Mentorship: Provide guidance and training to software engineers, product managers, and junior regulatory team members on medical device software development and regulations.
Company info
- Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process.
This listing is sourced directly from Heartflow's careers page and normalized into a canonical job model.