Head of Regulatory Affairs

Hippocratic AI is 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. The ideal candidate will have 10-12 years of regulatory affairs experience and a strong understanding of FDA regulations and the industry.

Requirements

• 10-12 years of regulatory affairs experience
• Bachelor's degree in life science
• 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
• Demonstrated ability to thrive in fast-paced, dynamic startup environments with limited structure and high ownership
• Excellent written and verbal communication skills, especially for FDA submissions and internal education

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance