Consultant at Antal International
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Medical Writer - Clinical Evaluation Reports (2-6 yrs)
Job Description
1. Author sections of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Post Market Clinical
2. Follow-up (PMCF) reports in compliance with EU MDR 2017/745.Support in PMS activities
3. Support in preparing dossier for FDA 510k submissions, including designing clinical validation studies
4. Independently monitors activities to compile, update, and maintain regulatory records
5. Coordinate with stakeholders from various departments across the company
