US Regulatory Consultant

United States . Remote

Project summary

We are looking for Regulatory Consultants with expertise in AI-enabled health tools to help evaluate and audit LLM health conversations against US FDA frameworks. In this role, you will help safeguard regulatory boundaries by reviewing AI outputs and refining evaluation rubrics in collaboration with safety and policy teams.

Project details

The project requires expertise in evaluating advanced AI models within the healthcare regulatory space. You will work closely with cross-functional AI safety, policy, and regulatory teams to analyze complex health dialogue edge cases and ensure compliance with US FDA guidance.

Responsibilities

Your responsibilities will be:

Assess LLM health conversations for regulatory risks.
Audit dialogue outputs against US-FDA CDS guidelines to spot SaMD boundary breaches.
Flag implicit diagnostic claims, treatment advice, or non-compliant medical claims.
Deliver expert annotations and rationale on complex health classification edge cases.
Refine evaluation rubrics in partnership with Regulatory, AI safety, and policy teams.

Requirements

Expertise in US FDA Regulatory frameworks such as Clinical Decision Support (CDS) guidance, Software as a Medical Device (SaMD) criteria, and General Wellness boundaries.
5+ years of experience in AI-enabled Regulatory Affairs preferred.

Compensation

For your valued time and insights, competitive hourly compensation will be provided based on experience and qualifications.

Interested in this role? Use Apply now above or email recruiting@medcase.health with questions. Our team will follow up with more information.

Apply Now

Designed for Practising Clinicians

Medcase engagements are built to complement active clinical practice—not replace it.

Project-based participation aligned with your specialty
Compensation for professional medical expertise
Flexible involvement without long-term commitments
Secure, compliant environments (HIPAA, GDPR)

Held to Clinical Standards

Not every contribution is equal in healthcare—and we treat it that way.

Credential verification and specialty matching
Structured review and calibration processes
Ongoing quality oversight by medical and project leads
Clear clinical and ethical guidelines

How Clinicians Contribute

Clinicians participate where medical judgment matters most in AI development.

Reviewing and validating medical data and model outputs
Providing expert clinical interpretation across modalities (text, imaging, video, waveform, audio)
Supporting clinician-led data annotation and enrichment
Advising on clinical accuracy, relevance, and edge cases
Contributing specialty-specific insight across regulated use cases

Professional Contribution, Fairly Compensated

Clinicians are compensated for their time and professional expertise.

Compensation details are shared transparently during the application and onboarding process
Participation is designed to fit alongside active clinical roles

6,000+ Health Care Professionals trust Medcase for flexible, rewarding project opportunities.

Join our network and start your fully remote part-time project today.