Digital Health FDA Consultant (SaMD - AI/Generative AI/LLMs)

Job Title: Digital Health FDA Consultant (SaMD - AI/Generative AI/LLMs)

Location: Remote (USA or India)

Engagement: Contract (Part-Time)

About the Role

We are seeking an experienced Digital Health FDA Consultant with deep expertise in Software as a Medical Device (SaMD) and hands-on experience guiding AI-driven products through the FDA clearance process. The ideal consultant will have strong knowledge of Generative AI, Large Language Models (LLMs), and AI-enabled disease diagnosis workflows, and can advise our team on regulatory, compliance, safety, and validation requirements.

This role is ideal for someone who has supported early-stage health tech or digital health companies in successfully navigating SaMD regulatory pathways.

Key Responsibilities

Provide end-to-end regulatory guidance for FDA SaMD submissions (510(k), De Novo, Pre-Sub, etc.)

Develop and review documentation including:

SaMD Risk Analysis (ISO 14971)

Clinical Evaluation Reports (CER)

Software Documentation per FDA and IMDRF

Validation/Verification Plans (V&V)

Human Factors and Usability documentation

Advise on regulatory strategy for AI/ML-enabled medical software, including:

Continuous learning algorithms

Model transparency, explainability, and bias mitigation

Real-world performance monitoring frameworks

Guide compliance with:

FDA's AI/ML SaMD Action Plan

Good Machine Learning Practices (GMLP)

21 CFR Part 820, Part 11, and FDA Digital Health Policies

Support development teams by translating regulatory requirements into:

Product requirements

Model performance metrics

Validation/clinical testing strategies

Assess and advise on the use of Generative AI and LLMs for disease diagnosis and clinical decision support

Prepare teams for FDA interactions and Q-Sub meetings

Conduct gap assessments for regulatory readiness and documentation completeness Required Qualifications

5-10+ years of experience in digital health, FDA regulatory consulting, or medical software compliance

Proven experience in FDA clearance for Software as a Medical Device (SaMD)

Hands-on experience with AI/ML-based medical devices, including algorithm validation and clinical evidence requirements

Familiarity with Generative AI, LLMs, and their application in diagnostics or decision-support tools

Strong understanding of:

IMDRF SaMD Framework

IEC 62304 (software lifecycle)

ISO 14971 (risk management)

FDA Guidance on Clinical Decision Support (CDS)

Demonstrated capability to work with engineering, data science, and clinical teams

Excellent communication skills and ability to simplify regulatory concepts for technical teams Preferred Qualifications

Experience with GenAI-enabled clinical decision support or diagnostic models

Prior work with health-tech startups or AI-driven digital health products

Understanding of HIPAA, PHI handling, and healthcare data governance

Knowledge of EU MDR/IVDR (bonus but not required)