Barun Sen
Lead Engineer|MDR|Post Market surveillance| Regulatory affairs|ISO 13485 |21CFR 820
- Role
- Lead Engineer at HCLTech
- Location
- Kolkata, WB, IN
- LinkedIn followers
- 500 followers
About Barun Sen
Worked in Wipro Limited as a Complaint Handling Specialist in Medical Device Reporting having experience of 2.5 years in Materiovigilance. Currently working as senior L1 investigator. Job responsibilities:*As a Complaint Evaluator my job roles include: Owning the complaint handling process including- 1. Complaints evaluation including adverse event reporting decisions, coding, initiating Good Faith Effort (GFE) follow up for additional information and closure of records. Assessment of Complaints(events) for proposed MDR reportability and submit assessments to client or regulatory authority. Assessment of the accurate Hazard code 4.Reportability assessment 5. Failure code assessment 6. Risk level assessment 7. complaint review and closure *As a Complaint Investigator my roles is: 1) Reviewing the records assessed by Evaluators 2) Investigating complaints 3) Writing of Investigation summary and Notes 4) Problem Source and reason code assessment 5) Creating Customer Response and market submitter response letter 6) Handling CAPA
Experience
Lead Engineer
Mar 2025 — Present · Madurai, IN
PMS complaint handling for Medical Devices
Education
Maulana Abul Kalam Azad University of Technology, West Bengal formerly WBUT
Bachelor of Pharmacy - BPharm
2016 — 2020
Bengal College of Pharmaceutical Sciences and Research 242
Bachelor of Pharmacy - BPharm
2016 — 2020
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