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 the European Union Medical Device Directive (EU MDD 93/42/EEC), the European Medical Device Regulation (EU MDR 2017/745, MEDDEV 2.7/...
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 the European Union Medical Device Directive (EU MDD 93/42/EEC), the European Medical Device Regulation (EU MDR 2017/745, MEDDEV 2.7/...
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