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

Location: Remote (USA or India)

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 IMDRFValidation/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 PlanGood 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 Qualifications5–10+ 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 FrameworkIEC 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