Rajeev Kumar Singh

Regulatory Manager @Trivitron Healthcare

Visakhapatnam, AP, IN
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jul 2021 — Present

Regulatory Manager @Trivitron Healthcare

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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

1994 — 2001

Rashtriya Military School, Dholpur

Schooling

2009 — 2010

Cliniminds, New Delhi

P.G Diploma

2003 — 2007

Allahabad Agricultural Institute

B. Pharmacy from A.A.I

SKILLS

Quality ControlErp (T.fat X3)GmpInternal AuditorMedical DevicesQuality AssurancePharmaceuticsIsoPharmaceutical IndustryLife SciencesQuality SystemSap Quality ManagementSap Quality ManagementInternal AuditorStandard Operating Procedure (Sop)

ABOUT RAJEEV KUMAR SINGH

Quality Assurance & Regulatory Affairs professional with 18+ years of expertise in…

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