Our client, a leading multinational company based in Galway, is seeking an Associate MDR Vigilance Specialist to join their team on a 23-month contract.
This is a hybrid role requiring 2 days of office work per week.
Responsibilities:
* Coordinate complaint handling activities for various Medtronic products, with a focus on pacemaker products.
* Receive and document incoming complaint events.
* C coordinate cross-functional activities in investigating customer complaints and determining root cause.
* Maintain and report Medical Device Reports (MDRs) accurately and completely as required by regulatory agencies.
* Support responses to queries from regulatory agencies regarding complaint events or post-market reports.
* Participate in risk management, risk analysis, and health hazard analysis related to complaint/post-market information.
* Contribute to continuous improvement initiatives to implement cell operating systems and principles within the CQXM department.
Requirements:
* Bachelor's degree in Engineering, Science, Legal, Clinical, or a related field.
* 1-2 years of experience in medical devices or a related environment preferred.
* Demonstrate teamwork skills, working effectively and proactively across functions.
* Apply critical thinking and make sound decisions.
* Maintain attention to detail.
* Understand basic anatomy, physiology, and medical terminology.
* Foster a patient-centric approach, setting high standards, promoting operational excellence, driving accountability, and modeling ethical behavior.
* Possess strong communication skills, being fluent in English, both written and spoken.