MDR/PMS Vigilance Specialist

Job description

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


  • Responsible for the oversight of complaint handling activities for a wide range of products
  • Responsible for the secondary approval of regulatory reporting decisions in a designate role
  • Responsible for the 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 complaint handling harmonization initiatives with other of our sites globally
  • 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 PXM department
  • Support problem solving initiatives within the department and coach or mentor other team members



  • We are looking for a qualified person to Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline and preferably with 2-3 years relevant experience in a medical devices or related environment
  • Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered
  • Team player who can work effectively and proactively on cross-functional teams Experience/understanding of complaint handling or CAPA processes are desirable
  • Able to think critically and make sound decisions
  • Focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour
  • Candidates must be a good communicator and are fluent in English, both in writing and speaking


To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent