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 c ompiling 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 gap assessment of the available version of CER with respect to MEDDEV Rev. 4 and MDR
    • Experienced in IVD regulatory Affairs, EU MDR/IVDR Gap Analysis, Performance Evaluation Report, Analytical & Clinical Report Reviews
    • Analyze and handle complaint data for regulatory submissions.
    • Proficient in updating the documents in accordance with ...

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