[Remote] Digital Health FDA Consultant (SaMD – AI/Generative AI/LLMs)

Note: The job is a remote job and is open to candidates in USA. Saviance is seeking an experienced Digital Health FDA Consultant with expertise in Software as a Medical Device (SaMD) and AI-driven products. The consultant will provide regulatory guidance for FDA submissions and support health tech companies in navigating SaMD regulatory pathways. 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 Skills • 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 • 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) Company Overview • Saviance is a modern consulting firm providing a variety of professional services to its clients in the US. It was founded in 1999, and is headquartered in East Rutherford , New Jersey, US, with a workforce of 201-500 employees. Its website is Apply tot his job