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Regulatory Affairs Specialist
Job description
Total Exp - 5-8 years Education - M pharma or Phd or Msc Location - Gurgaon Supports on CER remediation including developing search strategy for literature review and state-of-the-art (SotA); evaluating the data from MAUDE, HPRA or MHRA compiling information from various sources Update and review Periodic Safety Update Reports (PSUR) for medical devices. Prepare/ update Clinical Evaluation Reports (CER) in compliance with regulatory requirements for Medical Device Technical File (MDTF) Perform…
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