Personal Information
Organization / Workplace
Gurgaon, India India
Occupation
Quality and Regulatory Professional-Medical Devices
About
Currently working with Stryker Global Technology Center (R&D) as Associate Manager for Regulatory and Quality, having an overall experience of 15+ years with industry and 10+ years in Quality, Regulatory and Compliance functions of both Active/Non-active medical devices product development and manufacturing.
Keywords: ISO 13485:2003, 21 CFR 820 (QSR), EU Medical Device Regulation, MDD, IVD, FDA 510(k), CE marking IEC 60601-1,IEC 60601-1-6 (Usability) IEC 60601-1-8 (Alarms), IEC 62366, IEC 62304, IEC 14971, ISO/IEC 25051, Infant Care, Fetal Monitors, Orthopedics, Endoscopes, Software Quality & Regulatory, Project Management and Cross Functional Leadership.
RABQSA certified Lead Auditor f...
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