Regulatory Affairs Specialist

Role & Responsibilities
• Support CER (Clinical Evaluation Report) remediation including developing search strategy for literature review and state-of-the-art (SotA) evaluation
• Evaluate data from MAUDE, HPRA, or MHRA and compile information from various sources
• Update and review Periodic Safety Update Reports (PSUR) for medical devices
• Prepare and update Clinical Evaluation Reports (CER) in compliance with regulatory requirements for Medical Device Technical File (MDTF)
• Perform gap assessments of the available version of CER with respect to MEDDEV Rev. 4 and MDR (Medical Device Regulation)
• Experience in IVD (In Vitro Diagnostic) regulatory affairs, EU MDR/IVDR gap analysis, and performance evaluation report reviews
• Analyze and handle complaint data for regulatory submissions
• Proficient in updating documents in accordance with the European Union Medical Device Directive (EU MDD 93/42/EEC), the European Medical Device Regulation (EU MDR 2017/745), and MEDDEV 2.7/1 guidelines for the evaluation of clinical data
• Provide medical inputs with relevant and updated clinical evidence and monitor the execution of strategic documents like PBRERs, ACOs, DSURs, Clinical Overviews, Benefit/Risk assessments, and labelling documents
• Extensive experience in developing scientific writing content, including manuscripts, publication papers, online content, and academic content

Qualifications
• M. Pharma, Ph.D., or MSc in a relevant field
• 5-8 years of experience in regulatory affairs, particularly in medical devices and IVD

Skills
• Strong knowledge of regulatory requirements for medical devices, particularly EU MDR/IVDR
• Proficiency in regulatory writing and creating technical documents for clinical evaluations
• Experience in analyzing clinical data and complaint data for regulatory submissions
• Excellent communication skills for providing medical input and preparing reports

Benefits
• Competitive salary (not disclosed)
• Health insurance and other benefits

About The Company
• WNS is a global business process management company that delivers comprehensive solutions to industries across the globe, including the healthcare and life sciences sectors. The company is committed to maintaining high regulatory standards and supports its employees in their professional growth within a dynamic and collaborative work environment.