Regulatory Compliance Manager

The Department of Physics and Computational Radiology at Oslo University Hospital (OUH) has an opening for a one-year temporary position as a Regulatory Compliance Manager, with the possibility of extension.

This position is responsible for providing expertise, structure, and documentation to ensure our innovative software portfolio meets regulatory requirements ready for filing and subsequent market approval. The role involves preparing applications for marketing authorization for our team’s medical device (software) products. At the heart of our software development is CHRONOS, a patented (national phase) automatic decision-support system designed for early detection of structural disease changes, progression, or treatment response for any focal lesion in the brain. This technology aims to improve patient health outcomes, enhance physicians’ diagnostic accuracy, and optimize hospital resource utilization. Together with our research team, the regulatory compliance manager will focus on developing a Minimum Viable Product (MVP).

This is an exciting opportunity for a regulatory professional to contribute to cutting-edge medical innovations at Oslo University Hospital. If you have the required expertise and a passion for regulatory compliance, we encourage you to apply!

The applicant will be part of a research group on MRI Research & Technology headed by Dr. Kyrre E. Emblem, at the Department of Physics and Computational Radiology: https://www.ous-research.no/emblem/. The research group collaborate closely with many national and international research groups in Europe and the US, with emphasis on diagnosis, prognosis- and treatment response assessment in patients. The group also has a close link to industry through collaborations and co-development with software companies.

Department of Physics and Computational Radiology
The Department of Physics and Computational Radiology is part of the Division for Radiology and Nuclear Medicine at Oslo University Hospital (OUH). Our department includes over 70 people associated with clinical diagnostic physics and research. We also coordinate, and take part in, multiple national and international research studies. The primary tasks of the department include R&D in the fields of MR, PET and CT imaging, as well as serving OUH and most hospitals in the South Eastern Health Region in Norway.

Work tasks

Key Responsibilities of the position:

• Ensure regulatory compliance for medical innovations, including providing the required software documentation and certification under the European Medical Device Regulation (MDR).
• Establish and maintain Quality Management System (QMS) procedures in compliance with industry standards.
• Ensure data privacy compliance and implement regulatory solutions with minimal operational disruption.
• Support and train research staff on regulatory compliance, governance, and best practices.
• Ensure our innovation portfolio meets regulatory requirements for market approval.
• Oversee compliance for Class IIa medical devices, including EU conformity assessments and technical documentation.
• Act as regulatory lead, guiding product development from clinical studies to global market registration.
• Advise on clinical study regulations and their inclusion as reference documentation in regulatory filing
• Develop regulatory strategies for biomarker-based diagnostics in neurodegeneration, stroke, and oncology.
• Lead regulatory strategy in cross-functional projects and serve as the primary regulatory contact.
• Work closely with our research team, hospital managers, our technology transfer office Inven2, and regulatory authorities to ensure compliance.
• Provide expert regulatory advice to guide management decisions and maintain institutional and national regulatory alignment.

Qualifications

• Experience in Governance, Compliance, and Regulatory Affairs.
• Ability to implement and maintain QMS.
• Proven track record in IT compliance.
  
• Advanced university degree in Regulatory Affairs, Science, Technology, or Law.
• Documented experience in the medical device industry or with pharmaceutical regulatory agencies.
• Extensive knowledge of global regulatory requirements.
• Experience managing complex pre-market regulatory approvals.
• Demonstrated ability to interact with regulatory bodies and shape regulatory policies.
• Significant experience working with external regulatory agencies.
• Regulatory Affairs Certification (RAPS RAC).
• Experience with new medical device product launches.
• Expertise in software industry trade associations and standards.

Personal qualities

• Strong motivation
• Strong written and verbal communication skills in English (Norwegian/Scandinavian language skills are an advantage)
• High working capacity
• Excellent collaboration skills as well as ability to work independently.
• Positive attitude and goal oriented.
• Experiences with medical imaging and/or medical diagnostics are preferred.

We can offer

• A position in a highly skilled, multi-disciplinary and multi-cultural environment where you are encouraged to develop your skills and share your knowledge with your colleagues
• A position in an international research network with the opportunities to travel and meet other colleagues and researchers abroad.
• Young and friendly colleagues in a research area with a bright future.
• Access to state-of-the-art research infrastructure and data
• Most work may be performed remotely by secure access.
• Competitive benefits and focus on work-life balance.
• Appointment as Regulatory Compliance Manager/IT advisor will be for 1 year with the possibility for further engagement