AI Regulatory Strategy & Compliance
• Interpret and apply regulatory frameworks and guidance for AI-enabled medical devices, including FDA, EU MDR/IVDR, and global regulations.
• Define and drive AI regulatory strategies for clinical ultrasound features, including SaMD and AI-enabled device functions.
• Support FDA submission pathways (e.g., 510(k), De Novo, PMA) for AI-based features, including AI-specific regulatory positioning.
Risk Management & Safety for AI
• Lead AI-focused risk management activities in accordance with ISO 14971, addressing AI-specific hazards such as bias, robustness, generalization risk, and clinical misuse.
• Perform and maintain AI-specific risk analyses (e.g., AI FMEA, algorithm hazard analysis, clinical performance risk).
• Ensure traceability between clinical requirements, AI behavior, risk controls, and verification/validation evidence.
Regulatory Documentation & Submissions
• Prepare and maintain AI-related regulatory documentation, including:
• AI descriptions and intended use statements
• Training and validation dataset descriptions
• Performance evaluation and clinical evidence summaries
• Algorithm change management and lifecycle documentation
• Support creation of FDA-ready AI documentation, including transparency, explainability, and human-factors considerations.
AI Lifecycle & Change Management
• Define regulatory-compliant processes for AI updates, retraining, and post-market changes, aligned with FDA expectations.
• Support implementation of Predetermined Change Control Plans (PCCP) or equivalent AI lifecycle strategies.
• Ensure alignment between AI development practices and regulatory expectations for locked vs. adaptive algorithms.
Cross-Functional Collaboration
• Collaborate closely with:
• AI engineers and data scientists
• Clinical and medical affairs teams
• Quality, systems, and V&V engineers
• Product management and regulatory affairs
• Embed regulatory and safety requirements early into AI design, data strategy, and clinical validation plans.
Regulatory Intelligence & Audits
• Monitor evolving AI regulations, FDA guidance, standards, and industry best practices.
• Communicate regulatory changes and their impact on AI roadmaps and product strategy.
• Support internal audits, design reviews, and external regulatory inspections related to AI and clinical safety.
• Provide training and guidance on AI regulatory and safety topics to engineering and product teams.