MiamiRecruiter Since 2001
the smart solution for Miami jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest Florida jobs by following @recnetFL on Twitter!

Miami RSS job feeds