Ankur Datta
Recognized Regulatory & Quality Leader | Medical Devices & Diagnostics | 16+ Yrs in RA, QMS & Clinical Research | Driving Compliance & Innovation in MedTech | Ex, Abbott, HCL(Siemens), Avanos
- Role
- Manager (Head)-regulatory Affairs & Quality (India South Asia) at Teleflex
- Location
- Delhi, DL, IN
- LinkedIn followers
- 500 followers
About Ankur Datta
In healthcare, compliance is not paperwork — it is the framework that transforms…
Experience
Manager (Head)-regulatory Affairs & Quality (India South Asia)
May 2025 — Present · Noida, IN
Education
NITS,Bureau of Indian Standards
Internel Auditor, ISO 9001:2008 QMS/EHMO
2011 — 2011
American Inst. of Pharmaceutical Technology
PG Diploma, Clinical Research Associate
2007 — 2008
University of Calcutta
B.Sc, Microbiology
2002 — 2005
DNV
ISO 13485 QMS Internal Quality Auditor
2013 — 2013
Jamia Hamdard
Post Graduate Dilpoma, Pharmaceutical Regulatory Affairs
2012 — 2013
University of Kalyani
M.SC, Microbiology and Microbial Tech.
2005 — 2007
Skills
- Regulatory Submissions
- Iso 13485
- Clinical Trials
- Regulatory Affairs
- Regulatory Requirements
- Microbiology
- Change Control
- Quality System
- Ich-Gcp
- Document Management
- 21 Cfr Part 11
- Medical Devices
- Clinical Research
- Regulatory Guidelines
- Capa
- Good Laboratory Practice (Glp)
- Sop
- Fda
- Good Clinical Practice (Gcp)
- Protocol
- Validation
- Supplier Quality Management
- Gcp
- Glp
- Quality Assurance
- Standard Operating Procedure (Sop)
- Software Documentation
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