Compliant Handling And RA Specialist
Our client a leading medical device company require a specialist for complaint handling and post market regulatory reporting activities for a wide range of the company's 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.
- The oversight of complaint handling activities for a wide range of the company's products. And responsible for the secondary approval of regulatory reporting decisions in a designate role.
- 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.
- To continuous improvement activities to support the role out of cell operating systems and principles within the department.
Education, Experience and Skills
- Bachelor's degree (Level 8 NFQ) in Engineering/Science or related discipline
- Have 2-3 years relevant experience in a medical devices or related environment.
- 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.
For further information on this Compliant Handling And RA Specialist
Role in Galway please contact Cliona O'Malley on 091 730022/ firstname.lastname@example.org
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