Head of Regulatory Affairs

Head of Regulatory Affairs ABOUT US Hippocratic AI is the leading generative AI company in healthcare. We have the only system that can have safe, autonomous, clinical conversations with patients. We have trained our own LLMs as part of our Polaris constellation, resulting in a system with over 99.9% accuracy. WHY JOIN OUR TEAM Reinvent healthcare with AI that puts safety first. We’re building the world’s first healthcare‑only, safety‑focused LLM — a breakthrough platform designed to transform patient outcomes at a global scale. This is category creation. Work with the people shaping the future. Hippocratic AI was co‑founded by CEO Munjal Shah and a team of physicians, hospital leaders, AI pioneers, and researchers from institutions like El Camino Health, Johns Hopkins, Washington University in St. Louis, Stanford, Google, Meta, Microsoft, and NVIDIA. Backed by the world’s leading healthcare and AI investors. We recently raised a $126M Series C at a $3.5B valuation, led by Avenir Growth, bringing total funding to $404M with participation from CapitalG, General Catalyst, a16z, Kleiner Perkins, Premji Invest, UHS, Cincinnati Children’s, WellSpan Health, John Doerr, Rick Klausner, and others. Build alongside the best in healthcare and AI. Join experts who’ve spent their careers improving care, advancing science, and building world‑changing technologies — ensuring our platform is powerful, trusted, and truly transformative. Location Requirement We believe the best ideas happen together. To support fast collaboration and a strong team culture, this role is expected to be in our Palo Alto office five days a week, unless otherwise specified. ABOUT THE ROLE The Head of Regulatory Affairs is responsible for leading and executing global and domestic regulatory strategy, filings, and compliance activities for (a) clinical trials for pharmaceuticals, biologics, and medical devices, and (b) AI-driven SaMD products. This role requires a practitioner who not only knows FDA culture and regulatory frameworks, but can also operationalize them, drafting documents, building processes, and coordinating cross-functional activities. Successful candidates will be able to interface with our customer’s regulatory leads to ensure alignment and successful deployment of our AI in the pharma and medtech space. This role reports to the General Counsel, and will work closely with our legal, pharma, clinical, and IT teams. WHAT YOU'LL DO REGULATORY STRATEGY & EXECUTION - Help develop and support regulatory strategies and submissions for AI-enabled SaMD products, including classification, marketing applications (e.g., NDAs, De Novo, 510(k)), and pre-submission pathways. - Help develop and support regulatory documentation that enables our customers in the pharma and medtech space to meet their compliance obligations when using Hippocratic AI’s products. - Lead hands-on preparation of regulatory submissions with Legal: drafting sections, coordinating data inputs, managing timelines, and ensuring high-quality documentation. - Translate regulatory requirements into specific, actionable tasks for clinical, product, engineering, and quality teams. - Oversee and advance global and domestic regulatory and compliance initiatives, maintaining scientific accuracy, proactively managing risk, and keeping the organization aligned with changing regulatory expectations. REGULATORY COMPLIANCE - Build, manage, and continuously improve a practical regulatory compliance structure across SaMD development lifecycles. - Collaborate with legal, engineering, clinical, product, and quality teams to ensure compliance with applicable regulations, including 21 CFR Parts 210 and 211, 21 CFR Part 820, SaMD guidance, AI/ML-specific expectations and guidance, cybersecurity, and labeling requirements. - Help design, support, and maintain a compliant regulatory framework and Pharma-partner guidelines, including iterative AI development, model updates, QMS and GMP requireme ... (truncated, view full listing at source)