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Compliance Insight, Inc.

Cincinnati, Ohio

Closing Soon! Closing Soon!
www.bioxceltherapeutics.com

New Haven, Connecticut

Yale University

New Haven, Connecticut

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www.bioxceltherapeutics.com

New Haven, Connecticut

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Mirati Therapeutics

San Diego, California

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www.bioxceltherapeutics.com

New Haven, Connecticut

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Avanos

Alpharetta , Georgia

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Promega

Madison, Wisconsin

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Beckman Coulter, Inc.

Chaska, Minnesota

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Asensus Surgical

Durham, North Carolina

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Asensus Surgical

Durham, North Carolina

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Asensus Surgical

Durham, North Carolina

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University of Pittsburgh

Pittsburgh, Pennsylvania

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Orlando, Florida

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Santa Cruz, California

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Share Our Selves Community Health Center

Newport Beach, California

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Teachers College, Columbia University

New York, New York

Stanford Health Care

Palo Alto, California

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AdventHealth

Orange City, Florida

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University of Illinois Hospital & Clinics (UI Health)

Chicago, Illinois

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Banner Health

Phoenix, Arizona

Encompass Health

Alexandria, Alabama

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Regulatory Affairs Specialist
The Regulatory Affairs Specialist will provide regulatory guidance to study sponsors and IVD medical device manufacturers.  You will be responsible for the overall planning and direction of clinical regulatory activities.  In addition, you will develop and implement strategies in a collaborative environment between colleagues and clients with the goal of successful regulatory submissions. Responsibilities Lead project teams in support of Clients’ Regulatory and Clinical goals with the aim of bringing their products to market. Development, compilation, review and submission of U.S. Food and Drug Administration (FDA) Pre-Submission Meeting Submissions. Development, compilation, review and submission of Regulatory Filings such as FDA 510(k), de novo


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