Nilabja Dutta
QA- Post Market Quality Medical Device - QA/RA | Complaint Handling | Vigilance Reporting | QC Analyst | EU MDR | 21CFR PART 820, 803 | ISO-13485 | CSV Aspirant - IQ, OQ, PQ | TrackWise, SAP, ECM, Salesforce | EX - Wipro
- Role
- Complaint Management Specialist at HCLTech
- Location
- Kolkata, WB, IN
- LinkedIn followers
- 500 followers
About Nilabja Dutta
Pharmacovigilance professional with 4.6+ years of experience in drug safety and medical…
Experience
Complaint Management Specialist
Jun 2025 — Present
Led regulatory reporting for customer complaints including MDR, investigation, and post-market surveillance. Managed medical device complaint handling process in compliance with IMDRF guidance, ISO 13485, and FDA regulations. Investigated complaints, conducted hazard analysis, and collaborated cross-functionally to implement corrective actions. Utilized a decision tree-based system to classify and prioritize medical device complaints.
Education
Gupta College of Technological Sciences (GCTS), Asansol
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences
Maulana Abul Kalam Azad University of Technology, West Bengal (MAKAUT, WB)
Bachelor of Pharmacy - BPharm, Pharmacy
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