Associate Mdr & Vigilance Specialist

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 roll-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.
#J-18808-Ljbffr