Associate MDR/Vigilance Specialist

Associate MDR/Vigilance Specialist
Associate MDR/Vigilance Specialist opportunity for a well-established Pharma Manufacturing company, Medtronic. Based in Galway. 

Responsibilities may include the following and other duties may be assigned:

• Responsible for the co-ordination of complaint handling activities for a wide range of Medtronic products.
• Responsible for the the receipt and documenting of incoming complaint events.
• 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.

Key skills and experience:

• Qualified person to bachelor's degree (Level 8 NFQ) in Engineering/ Science or related discipline.
• Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered. 1-2 years relevant experience in a medical devices or related environment.
• Dynamic team player who can work effectively and proactively on cross functional teams.
• Ability to think critically and make sound decisions.
• Must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour.
• Good communicator and fluent in English, both in writing and speaking.