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 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.
• 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

Interested candidates please share your resume at shalini.kanwar@wns.com