y
yuwanesh

Yuwanesh T

@yuwanesh

Vigilance Specialist Quality and Regulatory

Inde
Anglais, Hindi, Tamoul
Certaines informations sont présentées en anglais.
À propos de moi
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.... Plus d’infos

Compétences

y
yuwanesh
Yuwanesh T
hors ligne • 

Voir mes services

Rédaction technique
I will provide medical writing for clinical and regulatory projects
De55 $US / projetPlus de détails

Expérience professionnelle

Cyient

Vigilance Specialist

Cyient • Temps plein

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 • Temps plein

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.