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yuwanesh

Yuwanesh T

@yuwanesh

Vigilance Specialist Quality and Regulatory

India
English, Hindi, Tamil
About me
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.... Read more

Skills

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yuwanesh
Yuwanesh T
Offline • 

See my services

Technical Writing
I will provide medical writing for clinical and regulatory projects
From$55 / projectMore details

Work experience

Cyient

Vigilance Specialist

Cyient • Full-time

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.

HCL_Healthcare

Lead Engineer, Post Market Surveillance

HCL Healthcare • Full-time

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.