My client, a major multinational based here in Galway, is looking to hire an Assoc MDR Vigilance Specialist on an initial 23-month contract.
This is a Hybrid role - 2 days in the office per week.
Responsibilities:
* 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.
* Contribute to continuous improvement activities to support the rollout of cell operating systems and principles within the CQXM department.
Requirements:
* 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.
For more information and a confidential discussion on the role, please contact Michelle Mc Inerney.
michelle.mcinerney@collinsmcnicholas.ie
091 706717
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