Samir Ghevariya, MS, MBA, RAC (Devices)
Regulatory Affairs Principal, New Product Development @ Cepheid
About
As an experienced regulatory affair professional, my aim is to contribute towards development of safe and effective medical devices for the betterment of the society and its people. Working as an only regulatory specialist at small to mid-size medical device organizations like Nubenco and Air Techniques has given me the opportunity to build a great foundation and experience in the field of regulatory affairs. My goal is to pursue challenging & rewarding career in the medical device industry, which would provide me with opportunities to fulfill organization’s goals and utilize this experience towards self-development and career growth.
United States
San Francisco Bay Area
Medical Device
510k, New Product Development, Regulatory Submissions, ISO 13485, Regulatory Affairs, GMP, Standard Operating Procedure (SOP), FDA, Clinical Trials, Quality Assurance, Documentation, Regulatory Compliance, Change Control, CAPA, Medical Devices, Corrective and Preventive Action (CAPA), Microsoft Office, Adobe Acrobat, Mac OS, Leadership
Experience

Quality Assurance Co-op
Glasston Pharmaceutical
Gujarat, India
Samir Ghevariya, MS, MBA, RAC (Devices)'s Contact Information
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