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HCA Healthcare

Tallahassee, Florida

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Boston, Massachusetts

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Minerva Surgical

Santa Clara , California

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El Paso, Texas

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AdventHealth

Wesley Chapel, Florida

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The Hospitals of Providence Sierra Campus

El Paso, Texas

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Chillicothe, Ohio

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Minneapolis, Minnesota

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Vanderbilt Health

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AdventHealth

Palm Coast, Florida

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DMC University Laboratories, Inc.

Detroit, Michigan

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Decatur, Georgia

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The George Washington University Hospital

Washington, D.C.

Meridian Bioscience

Nationwide

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Hardeeville, South Carolina

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Emanuel Medical Center

Turlock, California

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Delray Medical Center

Delray Beach, Florida

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MetroWest Framingham Union Hospital

Town of Framingham, Massachusetts

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Princeton Baptist Med Ctr

Birmingham, Alabama

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Good Samaritan Medical Center

West Palm Beach, Florida

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Saint Mary's Medical Center

West Palm Beach, Florida

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MGH Institute of Health Professions

Boston, Massachusetts

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Regulatory Submissions Specialist
Under general guidance, the Regulatory Submissions Specialist (R.S.S.) will create and assemble regulatory documents relating to the marketing and manufacture of medical devices.  This includes the determination of information required to accompany product (labeling and product insert sheets).  The R.S.S. will be responsible for regulatory documentation such as 510(k) submissions, regulatory and quality systems documentation requests from international distributors to support regulatory submissions and Notified Body submissions such as Notifications of Change as appropriate.  Prepare regulatory submissions. Responsible for the creation and assemblage of technical documentation on the products, including EU Technical Dossiers and Clinical Evaluation Reports.


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