Regulatory Compliance Manager

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.

• 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.

• 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.

• 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

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