Developed and managed Post Market Surveillance (PMS) Plans and Reports (PSUR, PMSR) to ensure compliance with global regulatory bodies.o Identifying gaps in procedures and report formats and provide recommendations for improvement.o Risk Assessment of the postproduction data and incorporate the findings into updated RM files.o Monitor Safety signals and perform through assessments of product complaints to identify safety risks and required action.Preparing Canada summary Reports upon in accordance with Medial device active license search from Health Canada.

Technical writing of the Post Market Surveillance Plan, Periodic Safety Update Report and PMS Report Under EU MDR 2017/745. Trend complaints, CAPA, SCA, Field action data using statistical tools.Collaborate with Cross Functional team (Clinical, QMS, Risk Management, Medical Safety) to obtain required data Liable for RC analysis. Participate the External and internal audits.Team player for assisting the Six Sigma Green belt project.

Conducting Process and Product Audit for Vendor Components.New Launch Product Quality Approval.Supplier PPM Calculation.