Our client, a medical device company in Galway are is currently looking to recruit a MDR Vigilance Specialist for their site.
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 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.
- Monitors the company's drug or medical devices surveillance program including the intake from all sources, evaluation, processing, and follow-up on complaints and adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
- Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), or adverse reaction data as required by regulatory agencies
- Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
- Support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports
- Support complaint trend analysis and annual post market surveillance reports for various products
- support complaint handling harmonization initiatives with other sites globally contribute to continuous improvement activities to support the role out of cell operating systems and principles within the PXM department support problem solving initiatives within the department and coach or mentor other team members.
- Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline
- 2-3 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 behaviour.
- Candidates must be a good communicator and are fluent in English, both in writing and speaking.
For further information on this MDR Vigilance Specialist role in Galway please contact Clara Burke on 086 8168273 / firstname.lastname@example.org
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