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Regulatory Affairs Manager

Company: Global Channel Management, Inc.
Location: Staten Island
Posted on: October 13, 2019

Job Description:

Regulatory Affairs Manager needs medical device Regulatory Affairs Manager requires: 8-10 years' experience in an FDA regulated Medical Device or Pharmaceuticals Industry 5 years' experience developing and executing Regulatory strategies for complex 510(k) and/or BLA development programs In Vitro Diagnostic Medical Device 10-20% travel, domestic working knowledge of US, EU, and International Regulations, FDA Bachelors degree in a Scientific or related Discipline is required, BSMT is a Regulatory Affairs Manager duties: Responsible for interpreting regulatory requirements and determining strategy to obtain registrations. Independently make decisions regarding work processes or operational plans and schedules in order to achieve department and project objectives.

Keywords: Global Channel Management, Inc., New York , Regulatory Affairs Manager, Executive , Staten Island, New York

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