Regulatory Affairs Specialist

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 2.7/1 Guidelines for the Evaluation of Clinical Data
Responsible to provide medical inputs with relevant and updated clinical evidence and to monitor the execution of other strategic documents as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit/Risk assessments and labelling documents for the corresponding therapeutic area or products.
Extensive experience in developing scientific writing content including manuscripts, publication papers, online content, and academic content

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