Gopinath Sasitharan
Deputy General Manager (Plant Head-quality and Regulatory Compliance) @Kriya Medical Technologies Pvt. Ltd
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WORK HISTORY
Deputy General Manager (Plant Head-quality and Regulatory Compliance) @Kriya Medical Technologies Pvt. Ltd
Chennai, IN
Overall responsible for EN ISO 13485:2016, MDSAP (Australia-TGA, Canada-HC, Brazil-Anvisa, United States-FDA, & Japan-MHLW) & MD-QMS implementation, certification, and maintenance for medical devices & IVD products.Product Handled: Insulin Pen Needle, Insulin Syringe, Blood collection tube (Vacuum, Non vacuum), Viral transport medium, Molecular transport medium, RTPCR Kits, Blood collection needles.Lead Auditor: ISO13485:2016; Internal Auditor: MDSAP & MD-QMS; Management Representative: Person Responsible for Regulatory Compliance (PRRC)Preparing and submission documents for Registration of Medical Device and IVDs, Manufacturing,License (class-A, B, C, & D), test license, Import license, Retention of manufacturing license, endorsement of product, Loan License, Market standing certificate, Non-conviction certificate, neutral code, Free sale certificate & Voluntary Registration of non-regulated Product as Guidelines: Indian MDR-2017
EDUCATION
Bioinformatics Institute of India
Diploma
Sikkim Manipal University
Master of Business Administration (M.B.A.)
University of Madras
B.Sc
University of Madras
M.Sc
SKILLS
ABOUT GOPINATH SASITHARAN
A qualified ISO13485:2016 lead auditor with over 18 years of industry experience…
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