Responsibilities. Responsible for the oversight of complaint handling activities for a wide range of business products. Timely submission of US 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. Provide oversight of clinical trial activity with respect to complaint handling, and provide appropriate support to the clinical teams as required, including interaction with clinical safety teams. Support risk management, risk analysis and health hazard analysis associated with complaint/post-market information. Interface directly with auditors/inspectors. You will also support any CAPA activities as required. Lead problem solving initiatives within the department and coach or mentor other team members. Education and experience. Third level Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline. 3-5 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 focused on patient safety and customer service, set high standards, instils operational excellence, Candidates must be a good communicator and are fluent in English, both in writing and speaking. Interested candidates should submit an updated CV. Please click the link below to apply, call Emma on 0214297900 or alternatively send an up to date CV firstname.lastname@example.org. This job originally appeared on RecruitIreland.com.
367 days ago