Head of Regulatory Affairs

We're seeking a Head of Regulatory Affairs to lead and execute global and domestic regulatory strategy, filings, and compliance activities for clinical trials and AI-driven SaMD products. This role requires a practitioner who knows FDA culture and regulatory frameworks, and can operationalize them.

Requirements

• 10-12 years of regulatory affairs experience spanning medical devices, digital health, pharmaceuticals, and related FDA-regulated products.
• Bachelor’s degree in life science required.
• Experience working at the FDA or directly interfacing extensively with FDA.
• Strong experience with FDA regulations and regulatory landscape.
• Strong understanding of industry, including clinical trials, drug and device development, patient support services, ad/promo, pharmacovigilance, and post-market activities
• Demonstrated experience preparing and submitting INDs, NDAs/BLAs, 510(k)s, De Novos, PMAs, supplements, and/or Q-subs.
• Strong experience with drug, device, and SaMD development, submissions, and regulatory pathways.
• Familiarity with AI-enabled medical technologies, machine learning considerations, and evolving FDA expectations for AI/ML.
• Excellent written and verbal communication skills, especially for FDA submissions and internal education.

Benefits

• Competitive salary
• Generous stock options
• Comprehensive benefits package
• Opportunities for professional growth and development