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 http://www.saviance.com.
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