About this role
Job Description Medical writing of the device related documentation Experience with EU MDR Regulation Experience drafting technical documentation for both US and EU (Technical files, GSPR, dossier sections) Experience with ISO 13485 QMS, 21 CFR 820 Experience with drafting SOPs, technical protocols and reports Experience with writing doc’s for Risk Assessments, Design and Process Verification, Biological Evaluation Experience working in the Pharmaceutical Industry Experience with drug-device combination products and design control documentation Working with and managing relevant vendors Work Experience 8-10Years Education Graduation in Science or Engineering Competencies