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ARMI | BioFabUSA

Manchester, New Hampshire

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Co-Diagnostics, Inc.

Salt Lake City, Utah

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Philips Electronics

Cambridge, Massachusetts

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Philips Electronics

Cambridge, Massachusetts

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Roehm America

Wallingford, Connecticut

Avanos

Alpharetta , Georgia

Grace Corporation

South Haven, Michigan

Grace Corporation

South Haven, Michigan

MDC Associates, Inc.

Beverly,

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Professional Disposables International

Woodcliff Lake, New Jersey

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Promega

Madison, Wisconsin

US Pharmacopeia

Rockville, Maryland

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Eisai

Woodcliff Lake, New Jersey

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UCLA Health

Los Angeles, California

Mammotome

Cincinnati, Ohio

American Regent

New Albany, Ohio

Philips Electronics

Charlestown, Massachusetts

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Celldex Therapeutics, Inc

New Haven, Connecticut

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DHL Supply Chain

Westerville, Ohio

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Allurion Technologies

01760, Massachusetts

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Overjet

Boston, Massachusetts

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Regulatory Affairs Manager
Develop, submit, maintain, and monitor standard operating procedures, policies, practices, and reports to assure compliance with all FDA and international medical device regulatory requirements and applicable standards. Primary Responsibilities: Prepares and evaluates regulatory documents and company specific SOP's, product manuals, Instructions for Use (IFUs), process flows and work instructions to maintain FDA QSR & ISO 13485 compliance. Prepares and assists in review and submission of regulatory submissions, product registrations and technical dossiers to FDA and EU Notified Bodies Audit and monitor internal processes and contract facilities for compliance with regulatory requirements, including FDA, CE, and ISO in applicatio


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