Sr. Software Engineer - AI Regulatory
Core
AI Regulatory Engineer bridging AI development, systems engineering, clinical workflow, quality systems, and regulatory requirements for AI-enabled medical devices.
Role type
Senior IC regulatory engineer (AI/ML medical devices)
Builds
compliant technical evidence and regulatory rationale for AI product registrations
Domain
Medical devices / AI/ML / Regulatory Affairs
Deliverable
production ML models
Required skills
AI/ML concepts, medical device development (SaMD), FDA/NMPA submissions, systems engineering, verification and validation, risk management, technical writing
Preferred skills
medical imaging, healthcare AI products, medical-device design controls, software lifecycle, AI performance evaluation
Responsibilities
Evaluate regulatory impact of AI model changes, translate technical decisions into regulatory rationale, develop technical evidence for product registrations, lead responses to regulatory deficiencies, maintain traceability among requirements and regulatory claims, collaborate cross-functionally to resolve regulatory risks
Seniority
Senior, hands-on IC
