AI Regulatory Engineer

About the role

GE HealthCare is looking for a proactive, detail-oriented AI Regulatory Engineer in Haifa to ensure that AI-based clinical features for ultrasound systems comply with evolving global regulatory requirements, particularly FDA regulations for AI-enabled medical devices. The role 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

• Interpret and apply regulatory frameworks for AI-enabled medical devices (FDA, EU MDR/IVDR, global regulations) and define AI regulatory strategies for clinical ultrasound features, including SaMD
• Support FDA submission pathways (510(k), De Novo, PMA) for AI-based features
• Lead AI-focused risk management under ISO 14971, covering bias, robustness, generalization risk and clinical misuse, and maintain AI-specific risk analyses (AI FMEA, algorithm hazard analysis)
• Prepare AI regulatory documentation: descriptions, intended use statements, dataset descriptions, performance evaluation summaries, algorithm change management and FDA-ready transparency and explainability documents
• Define processes for AI updates, retraining and post-market changes, and support Predetermined Change Control Plans (PCCP)
• Collaborate with AI engineers, clinical and medical affairs, quality, V&V engineers, product management and regulatory affairs, embedding regulatory and safety requirements early
• Monitor AI regulations and guidance, communicate their impact, 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 in a multidisciplinary team

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)