Job summary
This role supports the development and regulatory release of AI-enabled healthcare software by providing guidance on regulatory compliance and product release processes. The engineer collaborates with cross-functional teams to ensure adherence to regulatory requirements in AI, software, and model development within the healthcare industry.
Location and work setup
- Location
- Horten, Oslo
- Work setup
- On-site
Responsibilities
Provide regulatory oversight from concept to post-market activities for AI healthcare software products. Translate regulatory expectations into actionable product requirements. Support risk and change assessments, release readiness, and maintain technical documentation covering risk management, data governance, model performance, and validation. Evaluate regulatory impacts of software and model changes. Assist with submissions, audits, and regulatory inquiries, addressing issues such as model bias, robustness, explainability, and monitoring.
Qualifications
Experience in regulatory affairs related to medical devices, software as a medical device (SaMD), digital health, or healthcare software. Familiarity with AI/ML development processes and regulatory standards. Strong understanding of risk management, design controls, software lifecycle and change management. Proven ability to collaborate with technical teams and communicate effectively. Experience working within regulated product development environments.