MDR – Vigilance Specialist’s of All Levels

  • Reference: GJ556644
  • Job Type: Permanent
  • Location: Galway, Galway City, Mayo
  • Category: Medical Devices

At our Product Experience Management (PXM) group, which is part of the Galway PXM Complaint Handling and Regulatory Reporting Department, we focus on complaint handling and post market regulatory reporting activities for a wide range of Medtronic products. You will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting and Vigilance compliance. Spec will change depending on Seniority of the role with people and project managment involved.

You will be responsible for the oversight of complaint handling activities for a wide range of our products. You will be responsible for the secondary approval of regulatory reporting decisions in a designate role. You will also be responsible for the timely submission of US Medical Device Report (MDR) and EU Vigilance Reports to external 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 annual post market surveillance reports for various products. You will also support complaint handling harmonization initiatives with other client sites globally. 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. You will also support problem solving initiatives within the department and coach or mentor other team members. 

Qualifications


We are looking for a qualified person to Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline and preferably with 2-8 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. 

For confidential disscussion please call Christopher O Toole at Collins Mcnicholas, Galway on 091 706713

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Christopher O'Toole

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  • Christopher O'Toole
  • Principal Consultant & Team Lead
  • 091 706713
  • Connect with Christopher
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