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Assoc MDR/Vigilance Specialist
Our client, a medical device company in Galway are currently looking to recruit an Assoc MDR/Vigilance Specialist for their site.
- You will be responsible for the co-ordination of complaint handling activities for a wide range of products. You will be responsible for the receipt and documenting of incoming complaint events.
- You will also be responsible for co-ordination of cross-functional activities in the investigation of customer complaints and determination of root cause. You will also support Vigilance and Medical Device Report (MDR) programs including adverse event reporting, preparing documentation on adverse events and ensuring timely submission with relevant regulatory agencies.
- You will also support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports. You will also support complaint trend analysis and issuance of key report to relevant departments.
- You will support risk management, risk analysis and health hazard analysis associated with complaint/post-market information. You will contribute to continuous improvement activities to support the role out of cell operating systems and principles within the PXM department.
- We are looking for a qualified person to Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline and preferably with 1-2 years relevant experience in a medical devices or related environment.
- Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered.
- We are looking for a dynamic team player who can work effectively and proactively on cross-functional teams. Experience/understanding of complaint handling or CAPA processes are desirable.
- Candidates must be able to think critically and make sound decisions. Candidates must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical Behavior.
- Candidates must be a good communicator and are fluent in English, both in writing and speaking.
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