Head of Regulatory Affairs

About the Company

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.

Responsibilities

• Develop and support regulatory strategies and submissions for AI-enabled SaMD products, including classification and marketing applications.
• Lead hands-on preparation of regulatory submissions, including drafting sections and managing timelines.
• Translate regulatory requirements into actionable tasks for clinical, product, engineering, and quality teams.
• Build and manage a practical regulatory compliance structure across SaMD development lifecycles.
• Collaborate with cross-functional teams to ensure compliance with 21 CFR Parts 210, 211, and 820, as well as SaMD and AI/ML guidance.
• Develop and maintain SOPs, controlled documents, and audit readiness materials.
• Partner with legal, product, and engineering teams to define regulatory requirements early in development.
• Drive internal regulatory training and educate technical teams on FDA and pharmaceutical industry norms.

Requirements

• 10-12 years of regulatory affairs experience in medical devices, digital health, and pharmaceuticals.
• Bachelor's degree in life science.
• Experience working at the FDA or extensive experience interfacing with the FDA.
• Strong understanding of clinical trials, drug/device development, and post-market activities.
• Demonstrated experience preparing and submitting INDs, NDAs/BLAs, 510(k)s, De Novos, PMAs, or Q-subs.
• Familiarity with AI-enabled medical technologies and machine learning considerations.
• Ability to thrive in fast-paced, dynamic startup environments.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Experience in a startup or emerging-growth private company.
• Prior leadership experience building regulatory frameworks.
• PhD, PharmD, or Master's degree.
• RAC certification or equivalent.