Shailendra Roy

Experience

1. Business Analyst

   Genpact

   May 2023 — Present · Gurugram, IN

   Post Market Surveillance and Complaint Handling Global Customer Support and Issue Resolution• Investigated and addressed due diligence tasks related to incorrect or missing information and Vigilance requests.• Evaluated and coded customer inquiries, ensuring accurate closure of non-complaint cases and duplicate records.• Imported and updated data from auxiliary systems into the global IT system, maintaining data accuracy and efficiency.• Collaborated with Global Complaints Handling Management to identify and resolve quality issues associated with customer complaints.• Well-versed in US FDA 21 CFR Part 803, ensuring compliance with medical device reporting requirements.• Ensured adherence to FDA 21 CFR Part 803 guidelines by managing the collection, evaluation, and submission of adverse event reports.• Assessed adverse events according to FDA guidelines, accurately determining their reportability.•Monitored changes in regulatory requirements and guidelines, updating internal policies and procedures as needed.• Ensured compliance with ISO 13485:2016 by maintaining robust post-market surveillance processes and supporting quality management system (QMS) requirements.

Education

• North-Eastern Hill University

  Bachelor of Technology

  2015 — 2019