Akash

Medical Device Complaint Handling Specialist

Wipro • Full-time

Apr 2023 - Jan 2026 • 2 yrs 9 mos

I was responsible for end-to-end complaint handling and post-market surveillance of medical devices, ensuring compliance with ISO 13485, ISO 14971, FDA 21 CFR Part 820, and EU MDR. Key Responsibilities: Managing and documenting 150+ medical device complaints per week with 100% accuracy and regulatory compliance. Performing initial assessment, investigation, and root cause analysis of product complaints. Supporting risk management processes (ISO 14971) by identifying, documenting, and escalating potential product risks. Collaborating with R&D, QA/RA, and manufacturing teams for corrective and preventive actions (CAPA). Preparing reports for regulatory submissions and audits (FDA, ISO, EU MDR). Ensuring proper documentation within QMS, maintaining DHF, complaint records, and adverse event reporting. Contributing to internal audits and maintaining compliance with quality system regulations. Utilizing tools such as TrackWise, SAP, and MS Office (Excel – Pivot, VLOOKUP, reporting) for complaint trend analysis and regulatory reporting. Key Achievements: Consistently handled a high-volume caseload (150+ complaints/week) while ensuring timely closure and zero audit findings. Improved complaint documentation process, reducing cycle time and enhancing compliance. Gained hands-on exposure to post-market surveillance, CAPA, and regulatory documentation.