Job Description
We are seeking a Medical Device Writer with strong regulatory and clinical documentation experience to support the development, submission, and maintenance of EU MDR-compliant deliverables . This position plays a critical role in ensuring the accuracy, clarity, and quality of clinical and regulatory documents, while working cross-functionally with teams including Regulatory Affairs, Clinical Affairs, Quality, R&D, and Marketing.
The ideal candidate will have hands‑on experience preparing Clinical Evaluation Reports (CERs), Post‑Market Surveillance (PMS) plans/reports, PMCF documentation, and Summary of Safety and Clinical Performance (SSCP) . A sound understanding of EU MDR 2017/745 , MEDDEV 2.7/1 Rev. 4 , and relevant ISO standards is essential.
Key Responsibilities
- Author, edit, and maintain Clinical Evaluation Reports (CERs) in compliance with MEDDEV 2.7/1 Rev. 4 and EU MDR Annex XIV.
- Develop...