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Yuwanesh T
@yuwanesh
Vigilance Specialist Quality and Regulatory
India
Engels, Hindi, Tamil
Over mij
I am a Quality and Regulatory Analyst with over 5 years of experience in medical device complaint handling. I am a certified ISO 13485 Lead Auditor with expertise in EU MDR 2017/745, clinical medical writing, and process automation using Python and Power BI to improve regulatory efficiency.
Skills
Yuwanesh T
offline •
Bekijk mijn diensten
Technische teksten
I will provide medical writing for clinical and regulatory projects
Werkervaring
Vigilance Specialist
Cyient • Fulltime
Jun 2024 - Present • 2 yrs 5 mos
Manage end‑to‑end complaint handling, coding, investigations, and vigilance reporting for Class II/III devices; prepare MIR/MDR/AER submissions globally; automate reporting with Python, VBA, Power BI; perform audits, remediation, and team task allocation.
Lead Engineer, Post Market Surveillance
HCL Healthcare • Fulltime
Dec 2020 - Jun 2024 • 3 yrs 6 mos
Handled technical complaints for Class II/III medical devices, managed TrackWise intake and follow‑up, prepared MDR/MIR/AER submissions globally, conducted investigations with CAPA/FMEA, developed SOPs, dashboards, and led task allocation for compliance.
