Principal Regulatory Affairs Specialist

The role

This person will drive global regulatory strategy and submissions for AI-driven medical products. They will serve as a regulatory subject matter expert across SaMD, AI/ML algorithms, and mobile medical apps.

What you will do

• Represent Regulatory Affairs on cross-functional teams to ensure regulatory alignment.
• Author and execute global regulatory strategies including FDA Pre-submissions, 510(k)s, De Novo requests, and EU MDR CE Marking.
• Develop submission strategies for advanced digital health technologies including AI/ML-enabled devices.
• Lead interactive communications with regulatory agencies and 3rd party business partners.
• Maintain regulatory pre-market and post-market commitments and compliance.
• Support development of SOPs and internal guidance.
• Evaluate software changes under FDA and other software change guidances.
• Track evolving digital health policies and provide guidance to internal teams.
• Provide guidance and training to software engineers, product managers, and junior regulatory team members.

Required qualifications

• 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, 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 IEC 62304: Medical device software – Software lifecycle processes.
• Knowledge of ISO 14971: Application of risk management to medical devices.
• Knowledge of 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 have

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

About the company

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using cutting-edge technology. It is a publicly traded company that provides an AI-driven, non-invasive cardiac test.