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Senior Regulatory Affairs Associate

Company: Global Channel Management, Inc.
Location: New York
Posted on: June 15, 2019

Job Description:

Senior Regulatory Affairs Associate needs 4-6 years of experience in a regulated Medical Device Industry Senior Regulatory Affairs Associate requires: degree in a Scientific or related discipline working knowledge of US/EU/WW Regulations, FDA and WW guidance for Medical Devices (IVDs specifically), IVD Directive Experience developing regulatory strategies and an understanding of Product Development ability to work with business partners across geographies and time zones is critical Senior Regulatory Affairs Associate duties: Interpret Regulatory requirements and determine strategy to obtain registrations. Helps achieve departmental objectives through work processes. Partner with medical device Market Quality contacts, third parties, and distributors worldwide to develop regulatory strategies, resolve regulatory matters, and submit and maintain product registrations to gain and maintain market access for medical device products defined in the commercial business case. Assist in representing Company to domestic and international regulatory agencies, including Notified Bodies.

Keywords: Global Channel Management, Inc., New York , Senior Regulatory Affairs Associate, Other , New York, New York

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