Sudipta Ghosh
Biomedical engineer| Post Market Surveillance | Vigilance reporting specialist | Regulatory submissions to FDA, EU MDR and Health Canada | ISO 13485, 2016 | ISO 14971 | Trackwise | E submitter | Complaint handling.
- Role
- Lead Engineer at HCLTech
- Location
- Chennai, IN
- LinkedIn followers
- 500 followers
About Sudipta Ghosh
Experienced quality professional working at Wipro as a medical device complaint investigator for Sleep, Respiratory, Oxygen and Ventilators devices. Specialized on Adverse Event Reporting, Adverse event reporting (VENT) for market recall and non recall complaints, MDPR submissions, IRIS submissions, LINV Reporting and Manufacturer Incident Reporting along with submission to TUV, handling Good Faith Effort (GFE) and Follow-ups for additional information, Client handling specialist. I have skillset in Power BI, SAP documentation, e submitter, Salesforce and Trackwise.
Experience
Lead Engineer
Nov 2024 — Present · Chennai, IN
Education
University of Southern California
Master of Business Administration (MBA)
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