Head of Regulatory Affairs & Quality Control

What you'll do

• Develop regulatory strategies and prepare submissions and supporting documentation for AI-enabled SaMD and related drug and device products.
• Build and maintain compliance processes, including SOPs, controlled documents, audit readiness, and post-market monitoring.
• Translate regulatory requirements into actionable guidance and coordinate with cross-functional teams and customer regulatory leads.

What they ask for

• 8+ years of regulatory affairs experience spanning medical devices, digital health, and related FDA-regulated products.
• Bachelor’s degree in life science.
• Experience working at the FDA or extensive direct interaction with the FDA; strong knowledge of FDA regulations and the regulatory landscape.
• Demonstrated experience preparing and submitting INDs, NDAs/BLAs, 510(k)s, De Novos, PMAs, supplements, and/or Q-subs.

Nice to have

• Experience at a startup or emerging-growth private company.
• Prior leadership building regulatory frameworks or managing cross-functional initiatives; advanced degree, RAC certification, or equivalent is also a plus.

Tools

21 CFR Parts 210 and 211, 21 CFR Part 820, SaMD, AI/ML, QMS, GMP

AI focus

Regulatory strategy and compliance for AI-enabled SaMD, including AI/ML-specific expectations, iterative AI development, model updates, and post-market performance monitoring and mitigation.