Rajeev Kumar Singh
Regulatory Manager at Trivitron Healthcare
- Role
- Regulatory Manager at Trivitron Healthcare
- Location
- Visakhapatnam, AP, IN
- LinkedIn followers
- 500 followers
About Rajeev Kumar Singh
Quality Assurance & Regulatory Affairs professional with 18+ years of expertise in…
Experience
Regulatory Manager
Jul 2021 — Present · 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
1994 — 2001
Cliniminds, New Delhi
P.G Diploma
2009 — 2010
Allahabad Agricultural Institute
B. Pharmacy from A.A.I
2003 — 2007
Skills
- Quality Control
- Erp (T.fat X3)
- Gmp
- Internal Auditor
- Medical Devices
- Quality Assurance
- Pharmaceutics
- Iso
- Pharmaceutical Industry
- Life Sciences
- Quality System
- Sap Quality Management
- Sap Quality Management
- Internal Auditor
- Standard Operating Procedure (Sop)
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