AI Regulatory Affairs Specialist vs AI Remote Patient Monitoring Specialist

A AI Regulatory Affairs Specialist Only

• FDA SaMD regulatory pathways (510(k), De Novo, PMA) and the Predetermined Change Control Plan framework
• EU MDR/IVDR classification rules and EU AI Act high-risk AI system requirements
• AI/ML model lifecycle management: data provenance, model training, validation, deployment, and monitoring
• Risk management per ISO 14971 with AI-specific hazard analysis (data drift, distributional shift, automation bias)
• Clinical evaluation and real-world evidence generation for AI-enabled devices
• Software documentation per IEC 62304 and IEC 82304-1 for AI/ML components
• Explainability and interpretability methods (SHAP, LIME, attention visualization) from a regulatory perspective
• Bias detection, fairness auditing, and demographic performance disaggregation