An Associate MDR Vigilance Specialist is required by CareerWise Recruitment for our multinational medical device client in Galway for a fulltime, hybrid role on an initial 23-month contract. The Associate MDR Vigilance Specialist will be responsible for the co-ordination of complaint handling activities for a wide range of medical device products. THE ROLE: * Responsible for co-ordination of cross functional activities in the investigation of customer complaints and determination of root cause. * Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs) as required by regulatory agencies. * Support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports. * Support risk management, risk analysis and health hazard analysis associated with complaint/ post market information. * Contribute to continuous improvement activities to support the role out of cell operating systems and principles within the CQXM department REQUIREMENTS: * Bachelor's degree (Level 8 NFQ) in Engineering/ Science/ Legal/ Clinical or related discipline. * 1-2 years relevant experience in a medical devices or related environment preferred. * Dynamic team player who can work effectively and proactively on cross functional teams. * Ability to think critically and make sound decisions. * Strong attention to detail * Knowledge of basic anatomy, physiology, and medical terminology * Must be focused on patient safety and customer service, set high standards, instill operational excellence, drive accountability and model ethical behavior. * Good communicator and fluent in English, both in writing and speaking. You must have a Stamp 4 visa as a minimum requirement for this position. Please call Laura Gallagher today for further information on or email: CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. Skills: medical device vigilance complaint handling
