Healthcare AI Regulatory Engineer

GE HealthCare; Oslo fylke; Sur place; NOK 1 100 000 - 1 450 000; Plein temps

Résumé du poste

GE HealthCare seeks an AI Regulatory Engineer to guide AI-enabled healthcare software from concept to release, aligning with regulatory expectations across AI/ML product releases.

You will collaborate with data scientists, software engineers, data engineers, quality, clinical and product stakeholders to ensure compliant development and robust documentation. The role emphasizes risk assessments, change control, and post-market activities.

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.

Responsabilités

• 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.

Connaissances

Regulatory affairs experience

AI/ML regulatory expectations

Risk management

Design controls

Software lifecycle processes

Change control

Collaborative communication

Regulated product development

Description du poste

GE HealthCare seeks an AI Regulatory Engineer to guide AI-enabled healthcare software from concept to release, aligning with regulatory expectations across AI/ML product releases.

You will collaborate with data scientists, software engineers, data engineers, quality, clinical and product stakeholders to ensure compliant development and robust documentation. The role emphasizes risk assessments, change control, and post-market activities.