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 FFR_CTAnalysis—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 (FFR_CTAnalysis), 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 VC-backed company 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 400,000 patients worldwide.

This position will be key to building the next generation Heartflow regulatory affairs framework and will report to the Vice President of Regulatory Affairs and Quality Systems.

Required Qualifications

PhD. degree in Science, Engineering, or a related field and a minimum of 5 years of experience
Direct regulatory body work experience (e.g. FDA, Health Canada, PMDA)
In depth experience in advancing regulatory science for AI/ML medical device lifecycle management

How You Stand Out

Deep experience with machine learning concepts and frameworks, and the medical device software development (e.g., AAMI TIR45:2003)
Understanding computer science fundamentals to improve interaction between QARA and technology functions
Developing frameworks from proof-of-concept to improve traceability for AI/ML medical lifecycle as projects progress

A reasonable estimate of the base salary compensation range is $150,858 to $187,458, cash bonus, and stock options.

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.

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