Principal Regulatory Affairs Specialist

Regulatory Toolkit; San Francisco (CA); Vor Ort; USD 188.000 - 240.000; Vollzeit

Zusammenfassung

Heartflow, a medical technology company in San Francisco, seeks a Principal Regulatory Affairs Specialist to drive global regulatory strategy for AI-driven SaMD products. You will partner with Software, Data Science and Quality teams from planning through global clearance and post-market activities.

The role requires 10+ years in regulatory affairs for medical devices, with 4+ years in SaMD, and strong leadership and communication skills to mentor team members and align cross-functional plans.

Qualifikationen

• Bachelor’s degree in Computer Science, Biomedical Engineering, Software Engineering or related field.
• 10+ years of direct Regulatory Affairs experience in medical devices, with at least 4+ years focused on SaMD/SiMD/digital health.
• Direct experience clearing or approving SaMD (510(k), De Novo, CE Mark) with FDA/EU Notified Bodies.

Aufgaben

• Lead global regulatory strategy and submissions for SaMD and AI/ML-enabled devices.
• Collaborate with Software, Data Science, Product Management and Quality teams from planning to post-market activities.
• Engage with FDA Digital Health Center of Excellence, Notified Bodies and third-party partners.
• Maintain regulatory pre-market and post-market commitments and support SOP development.

Kenntnisse

Regulatory strategy

Regulatory submissions

FDA/EU regulations

Regulatory intelligence

Leadership

Communication skills

Ausbildung

Bachelor’s degree

Master’s degree

PhD

Tools

IEC 62304

ISO 14971

IEC 82304-1

Jobbeschreibung

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 FFRCTAnalysis—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 (FFRCTAnalysis), 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 PrincipalRegulatory 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.

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 atwww.heartflow.com/about/careers/