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QARA Engineer

Company: Emonics, LLC
Location: Miami
Posted on: January 27, 2023

Job Description:



Job Description: Responsibilities




  • Candidate must have at least 3-5 years of QARA experience from Medical Devices company.
  • Should have knowledge of regulation of Medical Devices for US FDA and Europe MDR.
  • Should be abreast with the upcoming regulatory changes into medical devices industry.
  • Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
  • Understand, investigate, and evaluate regulatory history/background of class, in order to assess regulatory implications.
  • Lead and executes EUMDR Transition projects (such as implementation of new/changed specific regulatory requirements).
  • Reviews Change Orders and assess regulatory impact of product changes per EUMDR and submissions per standard procedures.
  • Supports post market regulatory compliance activities.
  • Provides regulatory review of labeling, design changes, and specification changes.
  • Work with local RA teams, and develop International regulatory strategies for product submissions.
  • Work With cross functional team to lead & complete the technical file for EUMDR.
  • Work with offshore EUMDR Team.
  • Ability to perform all assigned tasks, work independently, and complete work on schedule.
  • Ability to communicate effectively in multi-discipline, cross cultural environment, and levels of organization.
  • Strong problem-solving skills and efficient management of time and resources.


Keywords: Emonics, LLC, Miami , QARA Engineer, Engineering , Miami, Florida

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