AI Regulatory Engineer to bridge AI development, systems engineering, clinical workflow, quality systems, and regulatory requirements for AI-enabled medical devices.
Responsibilities
Evaluate regulatory impact of AI model changes
Translate technical decisions into regulatory rationale
Develop and review technical evidence for AI product registrations
Lead technical analysis for regulatory deficiencies
Maintain traceability of product requirements and design decisions
Requirements
Master's degree or above in Biomedical Engineering, Computer Science, Medical Imaging, AI/ML, Software Engineering, or a related technical field
AI Regulatory Engineer bridging AI development, systems engineering, clinical workflow, quality systems, and regulatory requirements for AI-enabled medical devices
Responsibilities
Evaluate regulatory impact of AI model changes
Translate technical decisions into regulatory rationale
Develop and review technical evidence for AI product registrations
Coordinate responses to regulatory authorities
Maintain traceability of product requirements and design decisions
Requirements
Master's degree or above in Biomedical Engineering, Computer Science, Medical Imaging, AI/ML, Software Engineering, or a related technical field
Nice to have: Medical imaging or healthcare AI products
Nice to have: Regulatory submissions for AI-enabled medical devices
