Digital Health FDA Consultant

4 days ago

Boston, MA, United States Saviance Full time
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)

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