Regulatory Lead for AI Healthcare Platform

Hippocratic AI Inc.; Menlo Park (CA); On-site; USD 210,000 - 320,000; Full time

Job summary

Hippocratic AI Inc. seeks a Head of Regulatory to ensure our life sciences platform meets scientific, medical, and regulatory standards across geographies.

You will lead Regulatory Review cycle management, regulatory tracking, and regulatory review including non-promotional engagement—working with product, deployments, and external stakeholders. You will guide MLR processes, privacy obligations, and regulatory requirements across FDA/EMA contexts and partner with Legal/Compliance to meet HIPAA,

Qualifications

• 7–15 years of experience in regulatory operations or regulatory affairs within pharma/biotech/life sciences.
• Deep working knowledge of MLR review, non-promotional standards, medical information and adverse event reporting.
• Strong understanding of FDA and EMA frameworks for patient engagement and digital health tech.
• Ability to engage credibly with VP/SVP/C-suite across medical, regulatory, legal and compliance functions.
• Experience translating regulatory and medical requirements into operational or product specs.

Responsibilities

• Define and maintain regulatory standards governing patient- and HCP-facing interactions.
• Guide labeling operations, ensure evidence-based, non-promotional communications.
• Advise on regulatory requirements for medical inquiries, off-label questions, and clinical content.
• Partner with Product/Engineering to embed medical guardrails and clinical logic in workflows.
• Own regulatory strategy for pharma customer environments including MLR and privacy obligations.
• Support enterprise sales/deployments with regulatory credibility and governance resources.
• Translate learnings into repeatable regulatory playbooks and thought leadership.

Skills

Regulatory leadership

FDA/EMA knowledge

Stakeholder engagement

Regulatory operations

Medical affairs collaboration

Education

MD/PhD/PharmD or advanced degree

Tools

Regulatory systems (eCTD)

Medical affairs platforms

Job description

Hippocratic AI Inc. seeks a Head of Regulatory to ensure our life sciences platform meets scientific, medical, and regulatory standards across geographies.

You will lead Regulatory Review cycle management, regulatory tracking, and regulatory review including non-promotional engagement—working with product, deployments, and external stakeholders. You will guide MLR processes, privacy obligations, and regulatory requirements across FDA/EMA contexts and partner with Legal/Compliance to meet HIPAA,