Regulatory Affairs Consultant - FDA SaMD & AI Health

Location

Remote (USA) Commitment: Part-time, 10–20 hours per week Type: Contract / Consultant

About Medcase

Medcase is a global marketplace that connects organizations with on-demand medical expertise. Biotech, pharmaceutical, and AI companies, as well as CROs, rely on Medcase for telehealth, data labeling, annotation, surveys, interviews, and other specialized consulting services. Our network offers language-specific physician expertise across all clinical specialties, and we also partner with regulatory, quality, and technical experts to support companies building the next generation of healthcare technology. Medcase is growing and welcomes professionals interested in shaping the future of technology-enabled healthcare consulting.

About the Role

Medcase is looking for an experienced Regulatory Consultant with deep knowledge of US FDA frameworks to join a project evaluating AI-generated health conversations for regulatory risk. You will review LLM outputs, identify where they cross FDA regulatory boundaries, and provide expert rationale that helps shape how AI responds to health questions.

What You'll Do

• Assess LLM health conversations for regulatory risk.
• Audit dialogue outputs against FDA Clinical Decision Support (CDS) guidance to identify Software as a Medical Device (SaMD) boundary breaches.
• Flag implicit diagnostic claims, treatment advice, and non-compliant medical claims.
• Provide expert annotations and clear rationale on complex or ambiguous health classification edge cases.
• Partner with regulatory, AI safety, and policy teams to refine evaluation rubrics.

Required

• Deep expertise in US FDA regulatory frameworks, including CDS guidance, SaMD criteria, and General Wellness policy boundaries.
• 5+ years of experience in Regulatory Affairs.
• Based in the United States.

Preferred

• Experience with AI-enabled or digital health products.
• Sharp judgment on gray-area cases and the ability to explain your reasoning clearly in writing.
• Comfort working independently and asynchronously in a remote setting.

What We Offer

• Competitive hourly compensation based on experience and qualifications.
• Flexible, part-time schedule (10–20 hours/week).
• Fully remote within the US.

Interested? Apply now!

Work Location: Remote