Medical Writer/Consultant - Clinical Affairs Medical Devices | Medical Writer/Consultant (m/w/d) – Clinical Affairs Medizinprodukte
Iason consulting GmbH & Co. KG
Job Summary
This role involves creating, revising, and maintaining Clinical Evaluation Reports (CERs) for medical devices in English, ensuring compliance with MDR and relevant guidelines like MEDDEV 2.7/1 Rev. 4 and MDCG. The successful candidate will also draft other scientific documents for Clinical Affairs, including Literature Reviews, Post-Market Surveillance (PMS), and Post-Market Clinical Follow-up (PMCF) documents. Key responsibilities include researching and critically evaluating scientific and clinical publications and data, while ensuring consistency, traceability, and regulatory compliance of all documentation. Candidates with significant professional experience may also take on consulting services, project support, and management. This position offers an opportunity to work in a specialized, growing consulting firm with high professional expertise, engaging in exciting projects with leading medical technology companies.
Required Skills
Education
University degree in Medicine, Biosciences, Pharmacy, or a comparable field
Experience
- Professional experience in Medical Writing, ideally focused on clinical documentation for medical devices
- Professional experience in regulatory frameworks (MDR, MEDDEV, MDCG Guidance)
- Experience in consulting, project support, and management (for candidates with significant relevant professional experience)
Languages
Additional
- Not specified