Principal Regulatory Affairs Specialist

Heartflow•Rohnert Park, CA

6h•$188,000 - $240,000

About The Position

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.

Requirements

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.
Knowledge of software-specific standards and frameworks: IEC 62304: Medical device software – Software lifecycle processes
Knowledge of software-specific standards and frameworks: ISO 14971: Application of risk management to medical devices (including software hazard analysis)
Knowledge of software-specific standards and frameworks: IEC 82304-1: Health software – Part 1: General requirements for product safety
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.

Nice To Haves

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

Responsibilities

Represent Regulatory Affairs on cross-functional teams to ensure regulatory alignment with business objectives and generation of deliverables for regulatory submissions.
Author and execute timely global regulatory strategies including FDA Pre-submissions, 510(k)s, De Novo requests, EU MDR CE Marking, and other geographies.
Develop submission strategies for advanced digital health technologies, including AI/ML-enabled devices, Good Machine Learning Practice (GMLP), and Predetermined Change Control Plans (PCCPs).
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.
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.
Evaluate software changes under FDA and other software change guidances to determine necessary filings versus internal software release documentation.
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.
Provide guidance and training to software engineers, product managers, and junior regulatory team members on medical device software development and regulations.