Sayan Karar

About Sayan Karar

Detail-oriented and highly analytical Medical Device Tracking Analyst with 3 years of experience in managing and tracking of medical device data, ensuring regulatory compliance, and supporting product quality initiatives. Expertise in data analysis, data Entry & validation, tracking and trending reports using software tools like Track Wise. Skilled in monitoring product performance, managing device lifecycle data, and supporting post-market surveillance efforts to improve quality and regulatory outcomes. Utilized Track Wise software to manage and track regulatory complaints, ensuring compliance with FDA 21 CFR Part 803 and EU MDR reporting requirements.

Experience

1. Senior Associate

   Wipro

   Nov 2022 — Present

   Managed lifecycle of medical device complaints: intake, investigation, risk assessment, and regulatory reportability (FDA EMDR, EU MIR, Health Canada). Processed complaints via TrackWise; assessed adverse event classification using decision trees. Conducted Medical Record Reviews to extract operative and clinical data for IMDRF coding. Performed quality checks, peer reviews, and trained new hires on complaint-handling SOPs. Applied Six Sigma tools to enhance regulatory reporting accuracy. Validated device tracking products and managed device tracking closure records. Extracted and analyzed large datasets to identify quality issues and created dashboards/Pareto charts. Conducted quality audits, tracked non-conformities, and ensured timely audit record closures.

Education

• Garden Reach Mudiali High School

  Secondary

• JIS University

  Bachelor of Pharmacy - BPharm, Pharmacy

  2018 — 2022

• Garden Reach Enterprises

  High School Diploma, PCM

• JIS UNIVERSITY

  Bachelor's Degree

• Garden Reach Mudiali High School

  Higher Secondary

• JIS UNIVERSITY

  Bachelor, Pharmacy

  2022