Rajeev Kumar Singh
Regulatory Manager @Trivitron Healthcare
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WORK HISTORY
Regulatory Manager @Trivitron Healthcare
Visakhapatnam, IN
Preparation, compilation and submission of documents for getting Test Licence and Manufacturing Licence for IVD Kits, reagents, instruments or analyzers and molecular diagnostics kits or reagents.* Preparation, compilation and submission of documents for Wholesale Licence from State Licensing Authority.* Preparation, compilation and submission of documents for Test evaluation Licence, Import Licence for IVD kits, reagents, instruments or analyzer as per regulatory compliance of Indian MDR 2017 and implementation of IVDR.* Liaisoning with regulatory bodies (State Licensing Authority, Central Licensing Authority) and other Licensing notified bodies.* Conducting internal quality audit as internal quality auditor for ISO 9001:2015 and ISO 13485:2016.
EDUCATION
Rashtriya Military School, Dholpur
Schooling
Cliniminds, New Delhi
P.G Diploma
Allahabad Agricultural Institute
B. Pharmacy from A.A.I
SKILLS
ABOUT RAJEEV KUMAR SINGH
Quality Assurance & Regulatory Affairs professional with 18+ years of expertise in…
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