Head of Regulatory Affairs (Medtech)

TL;DR

Head of Regulatory Affairs (Medtech): Leading global and domestic regulatory strategy and compliance for AI-driven SaMD products and clinical trials with an accent on FDA filings and operationalizing regulatory frameworks. Focus on drafting submissions (NDAs, 510(k)s), building compliance structures for iterative AI development, and coordinating cross-functional alignment between legal, clinical, and engineering teams.

Location: Onsite in Palo Alto (expected in office five days a week)

Company

Leading generative AI company in healthcare building a safety-focused LLM for autonomous clinical conversations.

What you will do

• Develop and execute regulatory strategies for AI-enabled SaMD products, including classification and marketing applications (NDAs, De Novo, 510(k)).
• Lead hands-on preparation of regulatory submissions, drafting documentation and managing timelines in collaboration with Legal.
• Build and manage a practical regulatory compliance structure across SaMD development lifecycles, including QMS and GMP requirements.
• Translate complex regulatory requirements into actionable tasks for clinical, product, engineering, and quality teams.
• Interact with customer regulatory leads in pharma and medtech to ensure successful deployment of AI solutions.
• Design and maintain SOPs, controlled documents, and audit readiness materials.

Requirements

• 10-12 years of regulatory affairs experience across medical devices, digital health, and pharmaceuticals.
• Bachelor’s degree in life science required.
• Extensive experience interfacing with or working at the FDA.
• Proven track record of submitting INDs, NDAs/BLAs, 510(k)s, De Novos, or PMAs.
• Strong understanding of SaMD development, AI/ML considerations, and evolving FDA expectations.
• Ability to operate effectively in a fast-paced startup environment with high ownership.

Nice to have

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

Culture & Benefits

• Work alongside a world-class team of physicians, AI pioneers, and researchers from institutions like Stanford and Google.
• Opportunity to engage in category creation by building the first healthcare-only safety-focused LLM.
• Backed by top-tier investors including a16z, CapitalG, and General Catalyst with over $400M in funding.
• High-impact role focused on reinventing healthcare through safety-first AI.