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 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.
  • Pr...

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