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.
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/.
Heartflow is the global leader in AI-driven coronary artery disease (CAD) management, transforming how CAD — the world’s leading cause of death — is diagnosed and treated. Our advanced technology generates personalized, precision 3D heart models from a single CT scan, providing clinicians with the clarity and confidence to deliver earlier, more effective treatments — transforming CAD into a disease that can be managed for life.
Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform — including Roadmap™ Analysis, FFRCT Analysis and Plaque Analysis — is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications.
With over 400,000 patients treated, more than 1,400 leading institutions adopting our solution, and 99.5% of U.S. lives covered — Heartflow is redefining the standard of coronary care. We're a global company, with employees across the United States, Europe and Japan. Our headquarters are in Mountain View, California, with additional offices in California, Texas, the UK and Japan.
We believe CAD shouldn’t be a silent threat. We’re changing the story of CAD by making it screenable, diagnosable, and manageable — empowering clinicians to save lives and giving patients more time for what matters most.
