Heartflow - Principal Regulatory Affairs Specialist
Requirements
• Bachelor’s Degree in Computer Science (ML/AI), Biomedical Engineering, Software Engineering, Electrical Engineering, or a related scientific field. • Bachelor’s Degree • 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. • 10+ years • 4+ years • 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 • IEC 62304: Medical device software – Software lifecycle processes • IEC 62304: • ISO 14971: Application of risk management to medical devices (including software hazard analysis) • ISO 14971: • IEC 82304-1: Health software – Part 1: General requirements for product safety • IEC 82304-1: • 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. • Direct experience submitting Predetermined Change Control Plans (PCCPs) for AI/ML algorithms. • Predetermined Change Control Plans (PCCPs) • 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
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. • Product Development Team: • 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. • Strategic Roadmap: • 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). • Advanced Technology Filings: • 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. • External Engagement: • 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. • Quality System Support: • Software Change Impact Analysis: Evaluate software changes under FDA and other software change guidances to determine necessary filings versus internal software release documentation. • Software Change Impact Analysis: • 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. • Regulatory Intelligence: • Mentorship: Provide guidance and training to software engineers, product managers, and junior regulatory team members on medical device software development and regulations. • Mentorship:
Apply in one click
Upload My Resume
Drop here or click to browse · Tap to choose · PDF, DOCX, DOC, RTF, TXT