Principal Regulatory Affairs Specialist

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.

Required Qualifications

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