SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Salary: USD 188,000 - 240,000 / annual
HeartFlow is a publicly traded medical technology company (HTFL) pioneering AI-driven solutions for coronary artery disease diagnosis and management. The company's flagship product, HeartFlow FFR_CT Analysis, is a non-invasive cardiac test that provides 3D visualization of coronary arteries and blood flow assessment. The product is cleared in the US, UK, Europe, Japan, and Canada, and has been used for over 750,000 patients worldwide.
You will serve as Principal Regulatory Affairs Specialist, driving global regulatory strategy and submissions for HeartFlow's AI-driven medical products. This is a senior individual contributor and subject matter expert role focused on Software as a Medical Device (SaMD), AI/ML algorithms, mobile medical apps, and related products.
Key responsibilities include:
**Regulatory Project Management:**
- Represent Regulatory Affairs on cross-functional product development teams, ensuring regulatory alignment with business objectives and generating deliverables for regulatory submissions
- Author and execute global regulatory strategies including FDA Pre-submissions, 510(k)s, De Novo requests, EU MDR CE Marking, and submissions for 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)
- Lead interactive communications with regulatory agencies (FDA Digital Health Center of Excellence, Notified Bodies) and third-party business partners regarding algorithm performance evaluation and metrics
**Regulatory Operations and Compliance:**
- Maintain regulatory pre-market and post-market commitments and compliance (establishment registrations, certifications, reporting, special controls)
- Support development of SOPs and internal guidance; assist Quality organization in audits and initiatives
- Evaluate software changes under FDA and other software change guidances to determine necessary filings versus internal documentation
**Leadership & Digital Health Intelligence:**
- Track evolving digital health policies (FDA AI/ML Action Plans, EU Artificial Intelligence Act, ISO/IEC standards) and provide guidance to internal teams
- Mentor software engineers, product managers, and junior regulatory team members on medical device software development and regulations
**Required Qualifications:**
- Bachelor's degree in Computer Science (ML/AI), Biomedical Engineering, Software Engineering, Electrical Engineering, or 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. Alternatively: 6+ years with a Master's degree, or 4+ years with a PhD
- Direct experience successfully clearing or approving SaMD applications (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), 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)
- Ability to work toward established goals with minimal oversight
- Strong ability to translate complex software engineering language into clear regulatory rationale for health authorities
- Excellent written, verbal, and editing communication skills
- 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
