Director, Regulatory

About the Company

Hippocratic AI is the leading generative AI company in healthcare. We have the only system that can have safe, autonomous, clinical conversations with patients. We are building a new class of agentic AI that supports patients and healthcare stakeholders across the entire life sciences value chain.

Responsibilities

• Define and maintain regulatory standards for patient-facing and HCP-facing interactions
• Establish labeling operations frameworks to ensure accurate, evidence-based responses
• Advise on regulatory requirements for medical inquiries, off-label questions, and clinical content
• Partner with Product and Engineering to support medical guardrails and clinical logic
• Own regulatory strategy for pharma customer environments, including MLR review and adverse event reporting
• Guide internal teams and customers on FDA, EMA, and other jurisdictional requirements
• Provide medical and regulatory credibility during enterprise sales and RFP responses
• Translate learnings from deployments into repeatable regulatory and medical affairs playbooks

Requirements

• 7–15 years of experience in regulatory operations or regulatory affairs within pharma, biotech, or life sciences
• Deep knowledge of MLR review processes and non-promotional communication standards
• Strong understanding of FDA and EMA regulatory frameworks for digital health
• Proven ability to engage with C-suite stakeholders in medical, legal, and compliance functions
• Experience translating regulatory requirements into operational workflows or product specifications
• Exceptional written and verbal communication skills

Preferred Qualifications

• Experience with digital health platforms or AI in healthcare
• Familiarity with HIPAA, GDPR, and data privacy frameworks
• Experience supporting enterprise sales or technology deployments into large pharma
• MD, PharmD, PhD, or advanced scientific degree
• Startup or early-stage company experience