Our client is a global leader in the Medical Devices industry sector. They have undergone significant growth in the past year, and are seeking an experienced MDR/Vigilance Specialist to join the team at their state-of-the-art facility in Galway on a 12 month contract basis. Fully remote working options are available.

The Role

Duties and responsibilities of the MDR/Vigilance Specialist will include but are not limited to:

• Oversight of complaint handling activities for a wide range of products
• Overseeing secondary approval of regulatory reporting decisions
• Timely submission of US Medical Device Report (MDR) and EU Vigilance Reports to external regulatory agencies
• 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 risk management, risk analysis and health hazard analysis associated with complaint/post-market information
• Contribute to continuous improvement activities
• Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies
• Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements

The Person

You will have skills and experience in the following:

• BSc and 2+ years of relevant industry experience
• Candidates with a clinical/medical background will also be considered (e.g. registered nurse or experience in physiological or clinical measurement science)
• Experience/understanding of complaint handling or CAPA processes are desirable
• Audit experience desirable
• Must be a dynamic team player who can work effectively and proactively on cross-functional teams
• Must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.