A Major Multi - National Medical Devices Company in Galway,is seeking to fill the post of
MDR COMPLIANCE SPECIALIST
(Post also open to persons with legal or clinical qualification (e.g. Registered Nurse or experience in physiological or clinical measurement science)
At our Product Experience Management (PXM) group, which is part of the Galway PXM Complaint Handling and Regulatory Reporting Department in the Plant in Galway City, we focus on complaint handling and post market regulatory reporting activities for a wide range of Company 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.
You will be responsible for the oversight of complaint handling activities for a wide range of Company 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 Company 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.
Bachelor's degree (Level 8 NFQ) in Engineering/Science or related discipline and preferably with 2-3 years relevant experience in a medical devices or related environment.
(legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered).
A dynamic team player who can work effectively and proactively on cross-functional teams.
Experience/understanding of complaint handling or CAPA processes are desirable.
Ability to think critically and make sound decisions.
Focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical
A good communicator and are fluent in English, both in writing and speaking.
A very attractive Salary/Benefits Package is on offer and negotiable
Please forward your CV immediately to:
For informal enquiries, please ring Christy O'Hara on 087-9473404 or 00353 87 9473404 if outside Ireland