AI Regulatory Engineer
Core
Provide regulatory guidance and set directions for the engineering operation in AI/ML product releases within the healthcare industry.
Role type
Regulatory Engineer (AI/ML in Healthcare)
Builds
AI-enabled healthcare software (SaMD)
Domain
Healthcare / Medical Devices / AI Regulation
Deliverable
production ML models
Required skills
regulatory affairs for medical devices, SaMD, digital health, AI/ML development regulatory expectations, risk management, design controls, software lifecycle processes, change control
Preferred skills
project management, problem analysis and resolution, program execution
Technologies
AI/ML development frameworks
Responsibilities
Provide regulatory guidance from concept through product release and post-market activities; Translate regulatory expectations into practical requirements for AI, software, data, and model development; Support regulatory strategy, risk assessments, change assessments, and release readiness; Review and contribute to technical documentation including intended use, traceability, risk management, data governance, model performance, verification, and validation; Assess the regulatory impact of changes to software, models, training data, workflows, and intended use; Support submissions, audits, regulatory questions, and maintenance of product documentation; Help teams address topics such as model limitations, bias, robustness, explainability, monitoring, and version control