Our client is a global medical device healthcare solutions company who are committed to improving lives through medical technologies, services, and solutions. They operate across 350 facilities in 150 countries, with an innovative portfolio of over 46,000 patents.
There is an opening for an Associate MDR/Vigilance Specialist within the Product Experience Management (PXM) group at one of our client's sites in Galway. This group is part of the Complaint Handling and Regulatory Reporting Department and focuses on complaint handling and post market regulatory reporting activities for a wide range of products.
Reporting into the Quality Manager in the PXM Group, some of the responsibilities of the Associate MDR/Vigilance Specialist will include:
- Co-ordination of complaint handling activities for a wide range of products including receipt and documenting of incoming complaint events.
- Support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports.
- Monitoring the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow- up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
- 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.
The candidate must have:
- A bachelor's degree (Level8 NFQ) in Engineering/Science or related discipline and preferably with 1 -2 years relevant experience in a medical devices or related environment.
- Experience/understanding of complaint handling or CAPA processes are desirable.
- Be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour.
Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered.
To discover more about this opportunity, apply now or contact Helena Boyle at HRM on +353 1 6321870 or 0873360953 for a confidential discussion.