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CVRx, Inc.

Minneapolis, Minnesota

A-dec

Newberg, Oregon

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MGH Institute of Health Professions

Boston, Massachusetts

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AdventHealth

Rome, Georgia

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Amarillo, Texas

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Baylor Scott & White Health

Lakeway, Texas

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Geisinger

Wilkes-Barre, Pennsylvania

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HCA Healthcare

Ft Lauderdale, Florida

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Houston, Texas

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AdventHealth

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AdventHealth

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Baylor Scott & White Health

Irving, Texas

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Baylor Scott & White Health

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AdventHealth

Zephyrhills, Florida

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Johns Hopkins University

Baltimore, Maryland

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Veterans Affairs, Veterans Health Administration

Columbia, Missouri

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Veterans Affairs, Veterans Health Administration

Houston, Texas

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Harris Health System

Houston, Texas

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Baylor Scott & White Health

Irving, Texas

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CHRISTUS Health

San Antonio, Texas

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HCA Healthcare

Trinity, Florida

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Duke University Health System

Durham, North Carolina

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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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