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ASGCT

Nationwide

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Merck

Rahway, New Jersey

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Adaptive Biotechnologies

Seattle, Washington

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Ortho Molecular Products

Stevens Point, Wisconsin

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Adaptive Biotechnologies

Seattle, Washington

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Lumanity

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AuroMedics Pharma LLC

East Windsor, New Jersey

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Lumanity

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International Society for Pharmaceutical Engineering

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Port of San Francisco

San Francisco, California

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Xeris Pharmaceuticals

Chicago, Illinois

A-dec

Newberg, Oregon

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Carlsmed

Carlsbad, California

Medpace

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Sarah Rothenberg

Nationwide

Eisai

Nutley, New Jersey

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Kimberly-Clark

Neenah, Wisconsin

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Siemens Healthineers

Tarrytown, New York

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Endologix

Santa Rosa/Irvine, California

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Endologix

Irvine, California

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Summit Medical, LLC

Eagan, Minnesota

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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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