AI/ML Regulatory Engineer

About the role

GE Healthcare is hiring an AI Regulatory Engineer for its ultrasound research institute in Seongnam. The role ensures that AI-based clinical features for ultrasound systems comply with evolving global regulatory requirements, especially FDA regulations for AI-enabled medical devices. It works closely with AI engineering, clinical, quality, product management and regulatory affairs teams to define and execute the AI regulatory and submission strategy across the full product lifecycle.

Key responsibilities

• Lead AI-focused risk management in line with ISO 14971, covering 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) and keep traceability between clinical requirements, AI behaviour, risk controls and verification/validation evidence
• Prepare and maintain AI regulatory documentation, including AI descriptions, intended use statements, dataset descriptions, performance evaluation summaries, algorithm change management and lifecycle documentation, and FDA-ready documentation on transparency, explainability and human factors
• Define regulatory-compliant processes for AI updates, retraining and post-market changes, and support Predetermined Change Control Plans (PCCP)
• Collaborate with AI engineers, data scientists, clinical and medical affairs teams, quality and V&V engineers, product management and regulatory affairs, embedding regulatory and safety requirements early
• Monitor AI regulations, FDA guidance and standards, communicate regulatory changes, support audits, design reviews and inspections, and train engineering and product teams

Required profile

• Bachelor's or Master's degree in Engineering, Computer Science, Biomedical Engineering or a related field
• Experience in regulated medical device environments, preferably with AI-driven clinical features
• Solid understanding of medical device regulatory frameworks, with emphasis on FDA and EU MDR
• Experience with risk management methodologies and safety processes for medical devices
• Strong analytical, documentation and communication skills, able to work independently and collaboratively
• Fluent English communication preferred due to frequent collaboration with global teams

Preferred qualifications

• Experience with AI-enabled medical devices, SaMD or clinical decision support systems
• Familiarity with FDA guidance on AI in medical devices, Good AI Practice and AI lifecycle governance
• Experience supporting FDA submissions involving software or AI components
• Certification in regulatory affairs, quality or safety (e.g. RAC, TÜV, ASQ)
• Experience with global regulatory regions (US, EU, Asia)