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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
Competencies
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