
RANJITHKUMAR RADJARAME
Quality Support/Customer Support Assistant

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About me
Senior Technical Lead - Regulatory Affairs
Education

Vivekanandha Higher Secondary, India
2004 - 2006HSC- A level Equivalent Maths, Physics, Biology First Class
University of Bradford
2010 - 2011M.Sc MEDICAL ENGINEERING First Class Merit
Pondicherry University
2006 - 2010Bachelor of Technology (BTech) Biomedical/Medical Engineering First Class
Experience

Next Distribution Ltd
Oct 2011 - Jan 2014Quality Support/Customer Support Assistant
Sri Manakula Vinayagar Medical College & Hospital
Mar 2014 - Mar 2015Biomedical Engineer
Freelance
Apr 2015 - Feb 2016Freelance Trainer:
Staan Bio-Med Engineering Pvt Ltd
Feb 2016 - Feb 2017QARA Engineer
Wipro Technologies
Feb 2017 - Oct 2017QARA ENGINEER
HCLTech
Nov 2017 - nowSenior Technical Lead - Regulatory Affairs
Nov 2023 - nowTechnical Lead - Regulatory Affairs
Jul 2021 - Nov 2023Senior Analyst - Regulatory Affairs
Oct 2020 - Jun 2021Senior Analyst - Regulatory Affairs
Nov 2019 - Sept 2020Lead Engineer - Regulatory Affairs
Nov 2017 - Oct 2019

DePuy Synthes
Oct 2020 - nowRegulatory Affairs Specialist (On Contract through HCLTech)
Licenses & Certifications

EU Medical Device Regulation 745/2017
TUV SUD
CE Marking Overview
TÜV Rheinland Group
ISO 13485:2012 - Internal Audit
SGS- View certificate
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RAPS Member
Regulatory Affairs Professionals Society (RAPS)Feb 2025 - View certificate

Regulatory Compliance Certification - MDR
RAPS InstituteMay 2025 
ISO 13485:2016 OVERVIEW TRAINING
BSI
MDSAP - Internal Audit
BSI
Languages
- enEnglish
- taTamil
- teTelugu
- frFrench
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