Principal Regulatory Affairs Specialist
saludamedical
Principal Regulatory Affairs Specialist
heartflowinc· Regulatory Affairs
About this 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. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.
Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 750,000 patients worldwide.
We are seeking a Principal Regulatory Affairs Specialist to drive global regulatory strategy and submissions for our AI-driven Heartflow medical products. 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. 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.
Key Responsibilities
Regulatory Project Management
- Product Development Team: Represent Regulatory Affairs on cross-functional teams to ensure regulatory alignment with business objectives and generation of deliverables for regulatory submissions.
- Strategic Roadmap: Author and execute timely global regulatory strategies including FDA Pre-submissions, 510(k)s, De Novo requests, EU MDR CE Marking, and other geographies.
- 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).
- External Engagement: Develop relationships and lead interactive communications with regulatory agencies (e.g., FDA Digital Health Center of Excellence, Notified Bodies) and 3rd party business partners for Heartflow devices including algorithm performance evaluation and metrics.
Regulatory Operations and Compliance
- 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.
- Software Change Impact Analysis: Evaluate software changes under FDA and other software change guidances to determine necessary filings versus internal software release documentation.
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.
Required Qualifications
Education & Experience
- Bachelor’s Degree in Computer Science (ML/AI), Biomedical Engineering, Software Engineering, Electrical Engineering, or a related scientific field.
- 10+ years of direct Regulatory Affairs experience in medical devices, with at least 4+ years explicitly focused on SaMD, SiMD (Software in a Medical Device), or complex digital health solutions including deep knowledge in AI/ML. 6+ years and a Master’s degree; or 4+ years with a PhD.
- Direct experience successfully clearing or approving SaMD applications (e.g., 510(k), De Novo, or CE Mark) with FDA and/or EU Notified Bodies.
Technical Knowledge & Software Standards
- Knowledge of software-specific standards and frameworks:
- IEC 62304: Medical device software – Software lifecycle processes
- ISO 14971: Application of risk management to medical devices (including software hazard analysis)
- IEC 82304-1: Health software – Part 1: General requirements for product safety
Soft Skills & Cross-Functional Alignment
- Able to clearly work towards established goals and initiatives with minimal oversight.
- Strong ability to translate complex software engineering language into clear regulatory rationale for health authorities.
- Excellent communication skills (written, verbal, editing)
- Proven track record working effectively within software development environments.
- Strong organizational, leadership, interpersonal and influencing skills.
Preferred Qualifications
- Direct experience submitting Predetermined Change Control Plans (PCCPs) for AI/ML algorithms.
- Knowledge of clinical trial strategy and clinical study design
This position has an estimated base salary of $$188,000 - $240,000, bonus, and equity. #LI-IB1
Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. 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.
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. Before providing any personal information to outside parties, please verify the following: A) all legitimate Heartflow recruiter email addresses end with “@heartflow.com” and B) the position described is found on our careers site at www.heartflow.com/about/careers/.
Frequently Asked Questions
What is the salary for the Principal Regulatory Affairs Specialist role at heartflowinc?
The listed salary for this Principal Regulatory Affairs Specialist position at heartflowinc is USD 188K–240K. This is an full-time role.
Where is the Principal Regulatory Affairs Specialist position at heartflowinc located?
This Principal Regulatory Affairs Specialist role at heartflowinc is based in San Francisco, California; Rohnert Park, California. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Which team or department does the Principal Regulatory Affairs Specialist at heartflowinc belong to?
This Principal Regulatory Affairs Specialist position is part of the Regulatory Affairs department at heartflowinc. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Principal Regulatory Affairs Specialist position at heartflowinc?
Click the "Apply Now" button on this page. You will be redirected to heartflowinc's official application portal hosted on greenhouse where you can submit your application directly.
When was the Principal Regulatory Affairs Specialist job at heartflowinc posted?
This Principal Regulatory Affairs Specialist position at heartflowinc was posted on Oct 1, 2026. Apply as soon as possible — early applications are often reviewed first.
Principal Regulatory Affairs Specialist
heartflowinc · 💰 USD 188K–240K
You'll be redirected to heartflowinc's official application page on Greenhouse.