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Associate MDR

3 months ago

County Galway, Ireland Cpl Full time

Associate MDR & Vigilance Specialist


Requirements:


  • Responsible for the co-ordination of complaint handling activities for a wide range of Medtronic products, but more specifically pacemaker products.
  • Responsible for the receipt and documenting of incoming complaint events.
  • Responsible for co-ordination of cross functional activities in the investigation of customer complaints and determination of root cause.
  • Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs) as required by regulatory agencies.
  • Support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports.
  • Support risk management, risk analysis and health hazard analysis associated with complaint/ post market information dossier
  • Contribute to continuous improvement activities to support the role out of cell operating systems and principles within the CQXM department.

 

Key Skills & Experience


  • Bachelor's degree (Level 8 NFQ) in Engineering/ Science/ Legal/ Clinical or related discipline.
  • 1-2 years relevant experience in a medical devices or related environment preferred.
  • Dynamic team player who can work effectively and proactively on cross functional teams.
  • Ability to think critically and make sound decisions.
  • Strong attention to detail
  • Knowledge of basic anatomy, physiology, and medical terminology
  • Must be focused on patient safety and customer service, set high standards, instill operational excellence, drive accountability and model ethical behavior.
  • Good communicator and fluent in English, both in writing and speaking.


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