Medical Affairs Specialist

• Drive and maintain Clinical Evaluation Reports (CERs) on our existing portfolio to meet the requirements of the Medical Device Regulation (MDR) and other regulatory bodies
• Develop, plan, and write CERs for new indications for use and/or new products
• Handle and evaluate Post-Market Information data on an ongoing basis
• Write and update Periodic Summary Update Reports (PSUR)
• Provide input and support to development projects as well as other regulatory documents, like ‘Instructions for Uses’, usability reports, clinical risk documentation, etc.

• Master of Science degree, maybe complemented with a PhD or other types of research/clinical experience
• Previous experience as a medical/scientific writer of clinical and regulatory documents, is a plus, but not a requirement
• A critical, scientific mindset with a thorough understanding of research methodology, including statistical methods, study design and research concepts
• Strong analytical and communication skills
• Excellent written and verbal communication skills in both Danish and English
• Structured, result-oriented, committed and can handle changes in prioritization of tasks
• Thrive in a smaller company where you need to follow projects from one end to the other and contribute to an open and dynamic collaboration with your colleagues, from many different functional areas

Previous experience as a medical/scientific writer of clinical and regulatory documents

• Flex time
• Pension
• Canteen
• Health insurance
• A newly built, super nice office in Farum