Head of Regulatory Affairs (AI)

Location: Menlo Park office, onsite five days a week

Company

Hippocratic AI is a healthcare generative AI company developing safety-focused LLMs and autonomous clinical conversation systems for healthcare.

What you will do

• Lead global and domestic regulatory strategy, filings, and compliance for clinical trials, pharmaceuticals, biologics, medical devices, and AI-enabled SaMD products.
• Prepare FDA submissions, including classification strategies, marketing applications, pre-submission pathways, INDs, NDAs/BLAs, 510(k)s, De Novos, PMAs, supplements, and Q-subs.
• Draft submission sections, coordinate data inputs, manage timelines, and ensure accurate, high-quality regulatory documentation.
• Translate regulatory requirements into actionable work for clinical, product, engineering, quality, and legal teams.
• Build and improve regulatory compliance structures, SOPs, controlled documents, audit-readiness materials, and inspection response processes.
• Support customer deployments by working with regulatory leads in the pharmaceutical and medtech industries.

Requirements

• 10–12 years of regulatory affairs experience across medical devices, digital health, pharmaceuticals, and FDA-regulated products.
• Bachelor’s degree in life science required.
• Experience working at the FDA or extensively interfacing with the FDA, with strong knowledge of FDA regulations and regulatory pathways.
• Strong understanding of clinical trials, drug and device development, patient support services, advertising and promotion, pharmacovigilance, and post-market activities.
• Experience with drug, device, and SaMD development, submissions, AI-enabled medical technologies, machine learning considerations, and evolving FDA expectations.
• Excellent written and verbal communication skills, including FDA submissions and internal regulatory education.

Nice to have

• Startup or emerging-growth private company experience.
• Leadership experience building regulatory frameworks or managing cross-functional initiatives.
• PhD, PharmD, or Master’s degree.
• RAC certification or equivalent.

Culture & Benefits

• Work in a fast-paced startup environment with limited structure and high ownership.
• Build practical regulatory processes that support innovation, speed, safety, and responsible AI.
• Collaborate with clinical, technical, product, legal, quality, pharmaceutical, and executive stakeholders.
• Contribute to the regulatory foundation for advanced AI systems and traditional drug and device programs.