AI Regulatory Engineer
GE HealthCare · Horten
Job Description Summary
The AI Regulatory Engineer supports the development and release of AI-enabled healthcare software, and will provide guidance and set directions for the engineering operation in the area of AI/ML Product Releases within the healthcare industry. The position will work as an integrated member of cross-functional teams alongside Data Scientists, Software Developers, Data Engineers, Quality, Clinical, and Product stakeholders.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, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities.
Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.
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Additional Information
Relocation Assistance Provided: No
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