Our client is a global leader in the Medical Devices industry sector. They have undergone significant growth in the past year, and are seeking an Associate MDR/Vigilance Specialist to join the Customer Quality Experience Management (CQXM) group at their state-of-the-art facility in Galway on a 12 month contract basis. Fully remote working options available for now, but ideally you will be based in the West going forward.

The successful candidate 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 (MDR) and Vigilance Compliance.

The Role

Duties and responsibilities of the Associate MDR/Vigilance Specialist will include but are not limited to:

• Part of a team responsible for the management of all incoming product events from a range of sources and geographies.
• Responsible for the data entry of field complaints reported for medical devices into complaint database, including documentation review and complaint assessment.
• Support Vigilance and Medical Device Report (MDR) regulatory reporting by ensuring timely assessment of incoming complaint events.
• Support complaint trend analysis and issuance of key reports to relevant departments.
• Contribute to continuous improvement activities to support efficiency and productivity gains opportunities within the department.
• Build product knowledge and technical expertise of the product group you support.
• Adherence to procedures at all times to ensure compliance.
• Ensure highest quality of product event data entry for accuracy of reporting to regulatory agencies.
• Ensures complete and accurate maintenance and reporting of Medical Device.

The Person

You will have skills and experience in the following:

• Minimum Level 8 Degree in Engineering / Science or related discipline.
• Dynamic team player, attention to detail, goal-orientated, good communicator and problem solving skill sets.
• Medical Device experience is preferable (6 months to 2 years).
• Good communicator and fluency in English, both in writing and speaking.

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on 086 170 0408 for a confidential discussion.