Associate MDR/Vigilance Specialist

Recruiter
Medtronic
Location
Galway
Salary
Negotiable
Posted
25 Nov 2022
Closes
23 Dec 2022
Ref
BBBH5436
Contact
Zaharia Ahmed
Sector
Engineering
Job Type
Contract
Hours
Full-time

Associate MDR/Vigilance Specialist
Associate MDR/Vigilance Specialist opportunity for a well-established Pharma Manufacturing company, Medtronic. Based in Galway. 

Responsibilities may include the following and other duties may be assigned:

  • Responsible for the co-ordination of complaint handling activities for a wide range of Medtronic products.
  • Responsible for the 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.
  • Contribute to continuous improvement activities to support the role out of cell operating systems and principles within the CQXM department.


Key skills and experience:

  • Qualified person to bachelor's degree (Level 8 NFQ) in Engineering/ Science or related discipline.
  • Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered. 1-2 years relevant experience in a medical devices or related environment.
  • Dynamic team player who can work effectively and proactively on cross functional teams.
  • Ability to think critically and make sound decisions.
  • Must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour.
  • Good communicator and fluent in English, both in writing and speaking.

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