AI Regulatory Engineer

Job description

Job Description

Responsibilities

Provide regulatory guidance from concept through product release and post-market activities.

Translate GEHC 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.

The ideal candidate is hands-on, pragmatic, and comfortable participating in technical discussions, team planning, risk reviews, and release activities.

Required Qualifications

Experience with regulatory affairs for medical devices, SaMD, digital health, or healthcare software.

Familiarity with AI/ML development and related regulatory expectations.

Understanding of risk management, design controls, software lifecycle processes, and change control.

Ability to collaborate effectively with technical teams and communicate clearly.

Experience working in regulated product development environments.

Desired Characteristics

Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.

Inclusion & Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation,