AI Healthcare & Life Sciences Advanced
AI Regulatory Affairs Specialist
An AI Regulatory Affairs Specialist ensures that AI- and ML-driven medical devices, digital therapeutics, and clinical decision-su…
Demand 9.1/10
AI Risk 15%
Salary $105,000-$195,000/yr
FDA SaMD regulatory pathways (510(k), De Novo, PMA) and the Predetermined Change Control Plan frameworkEU MDR/IVDR classification rules and EU AI Act high-risk AI system requirementsAI/ML model lifecycle management: data provenance, model training, validation, deployment, and monitoringRisk management per ISO 14971 with AI-specific hazard analysis (data drift, distributional shift, automation bias) +8