Job summary
This role involves supporting the development and regulatory compliance of AI-enabled healthcare software. The position provides regulatory guidance throughout the software lifecycle, ensuring adherence to relevant medical device and digital health standards. The candidate will collaborate closely with multidisciplinary teams including data scientists, software developers, and clinical stakeholders to facilitate safe and effective AI product releases within a regulated environment.
Location and work setup
- Location
- Gjøvik, Oslo
- Work setup
- On-site
Responsibilities
Manage regulatory activities from concept to post-market support for AI healthcare software products. Translate regulatory requirements into actionable guidelines for AI, software, data, and model development teams. Perform risk and change assessments related to software, models, and workflows. Review and contribute to technical documentation addressing risk management, data governance, performance verification, and validation. Assist in regulatory submissions, audits, and addressing regulatory inquiries. Guide teams on AI-specific considerations such as bias, robustness, explainability, monitoring, and version control.
Qualifications
Experience in regulatory affairs related to medical devices, software as a medical device (SaMD), digital health, or healthcare software is required. Familiarity with AI/ML development processes and associated regulatory frameworks. Solid understanding of risk management, design controls, software lifecycle, and change management procedures. Proven ability to collaborate effectively with technical teams and communicate clearly in a regulated product development setting. Strong problem-solving and project management skills are advantageous.