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