Samir Ghevariya, MS, MBA, RAC (Devices)

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.

Country

United States

City

San Francisco Bay Area

Industry

Medical Device

Skill

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

Cepheid

Regulatory Affairs Principal, New Product Development

Cepheid

LinkedIn
2024-4 - Present · 2 yrs 6 mos
Cepheid

Regulatory Affairs Sr. Specialist, New Product Development

Cepheid

LinkedIn
2021-8 - 2024-4 · 2 yrs 9 mos

Greater Chicago Area

Air Techniques

Regulatory Affairs Specialist

Air Techniques

LinkedIn
2018-10 - 2021-7 · 2 yrs 10 mos

Greater New York City Area

Nubenco Enterprises, Inc.

Regulatory Affairs Specialist

Nubenco Enterprises, Inc.

LinkedIn
2016-8 - 2018-10 · 2 yrs 3 mos

Greater New York City Area

Long Island University

Teaching Assistant

Long Island University

LinkedIn
2015-5 - 2016-5 · 1 yr 1 mo

Brooklyn, New York

Unichem Laboratories Limited

Clinical Associate

Unichem Laboratories Limited

LinkedIn
2012-7 - 2013-12 · 1 yr 6 mos

Mumbai Area, India

Glasston Pharmaceutical

Quality Assurance Co-op

Glasston Pharmaceutical

2011-5 - 2012-1 · 9 mos

Gujarat, India

Education

LIU Brooklyn

LIU Brooklyn

LinkedIn

Regulatory Affairs

2014 - 2016 · 2 yrs
Campbellsville University

Campbellsville University

LinkedIn
2018 - 2020 · 2 yrs

Samir Ghevariya, MS, MBA, RAC (Devices)'s Contact Information

Email

******@***.com

Phone

(**) *** ****

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