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New · posted Oct 15

HeartFlow · Medical Devices

Principal Regulatory Affairs Specialist

  • San Francisco, CA +1 more
  • On-site
  • Full-time
  • Senior & Principal
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Pay$188K–$240Ka year · employer provided
EmploymentFull-time
LocationSan Francisco, CA +1 moreOn-site
LevelSenior & Principal
FunctionRegulatory AffairsRegulatory
Deadline

Open until filled

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. 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.

What you need

  • 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 Qualificationsnice to have

  • Direct experience submitting Predetermined Change Control Plans (PCCPs) for AI/ML algorithms.
  • Knowledge of clinical trial strategy and clinical study design

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/.

Skills named in this posting

What you'll do

Regulatory Project Management

  1. Product Development Team: Represent Regulatory Affairs on cross-functional teams to ensure regulatory alignment with business objectives and generation of deliverables for regulatory submissions.
  2. 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.
  3. 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).
  4. 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

  1. 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.
  2. 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

  1. 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.
  2. Mentorship: Provide guidance and training to software engineers, product managers, and junior regulatory team members on medical device software development and regulations.

Pay and benefits

$188,000 – $240,000 a year

Employer provided
How this compares

This position has an estimated base salary of $$188,000 - $240,000, bonus, and equity.

  • Bonus

  • Equity

Where you'll work

San Francisco, CA +1 moreOn-siteOpen in Maps (opens in a new tab)

Also posted for: Rohnert Park, CA

More jobs in San Francisco, CA +1 more
Equal opportunity, accessibility and legal noticesHeartFlow's statements, word for word

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.

Job intelligence

The context around this role

Live data · October 15, 2026

Salary intelligence

How the pay compares

This role's midpoint is 56% above the US median for Regulatory Affairs roles at this level.

This roleEmployer provided

$188,000 to $240,000 a year

Senior & Principal roles in California17 roles publishing pay

Middle half $130,000 to $150,000, median $137,500

Senior & Principal roles in the US53 roles publishing pay

Middle half $115,000 to $150,000, median $137,500
Annual base pay
Annual base payLowMedianHigh
This role$188,000—$240,000
California$130,000$137,500$150,000
All US$115,000$137,500$150,000

This role: HeartFlow's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Regulatory Affairs

The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not HeartFlow's own promotion track.

  1. One step back

    Associate & Specialist

    Often: Regulatory Affairs Specialist · Summer 2027 Internship

    $90K median34 open

  2. This role

    Senior & Principal

    Often: Senior Regulatory Affairs Specialist · Principal Regulatory Affairs Specialist

    $138K median69 open

  3. Next step

    Manager

    Often: Regulatory Affairs Manager · Manager, Regulatory Affairs

    $163K median59 open

  4. Later

    Director

    Often: Director, Regulatory Affairs · Senior Director, Regulatory Affairs

    $235K median110 open

  5. Later

    VP & Executive

    Often: Vice President, Regulatory Affairs · Global Head of Injectable Aesthetics Regulatory Strategy

    $321K median18 open

Career resources on Regulatory Affairs

Skills DNA

What this role leans on

How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 2 linesLab testing and methods: 1 lineDocumentation and SOPs: 3 linesRegulatory submissions: 6 linesQuality systems and risk: 4 linesData and digital systems: 8 linesCollaboration and leadership: 8 linesGMPLab testingDocumentationSubmissionsQuality systemsData systemsTeamwork
  • Data and digital systems8
  • Collaboration and leadership8
  • Regulatory submissions6
  • Quality systems and risk4
  • Documentation and SOPs3
  • GMP and compliance2
  • Lab testing and methods1

Regulatory intelligence

The rules behind this role

Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

HeartFlow on Regulatory Jobs

5
Open roles
5
Distinct roles
1
Locations

By discipline

  • Quality3 60%
  • Regulatory1 20%
  • Compliance & Safety1 20%

By level

  • Senior & Principal3 60%
  • Director1 20%
  • Manager1 20%
See all 5 HeartFlow roles

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Principal Regulatory Affairs Specialist at HeartFlow

Open until filled. $188K–$240K a year, employer provided.

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    Principal Regulatory Affairs Specialist at HeartFlow — San Francisco, CA +1 more | Regulatory Jobs