What you need to know
You will work as the MDR Vigilance Specialist for our client, a highly successful and established medical device company in Galway.
You will work alongside the Complaint Handling and Medical Device Regulatory department providing value throughout the Product Life cycle through world-class execution in Medical Device Reporting and Vigilance compliance.
This is a permanent role.
Your new job
Key duties & responsibilities:
- Monitor the organisations drug or medical device surveillance program.
- Follow-up on complaints & adverse reports, assisting in the resolution of any legal liability ensuring to comply with government regulations.
- MDRs (Medical Device Reports) – ensure complete & accurate maintenance and reporting as required by regulatory agencies.
- Liaise internally and externally with collaborators developing programs and processes to meet regulatory reporting requirements.
- Support the response to any queries received from regulatory agencies concerning complaint events or post-market regulatory reports.
- Coordinate complaint trend analysis and annual post-market surveillance reports for various products.
- Work with other sites globally to support complaint handling harmonization initiatives.
- Contribute to continuous improvement activities to support the role out of cell operating systems and principles within the PXM department.
What are we looking for?
- Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline. Please note candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered.
- At least 2-years relevant experience in a medical device environment.
- Dynamic team player who can work effectively and proactively on cross-functional teams.
- Strong communication skills.
- Excellent customer service skills.
- Experience of complaint handling or CAPA processes.
Apply for this job now or get in touch with Áine on 090 64 90485.
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgment email and a request for consent where not already expressly given.
We Value Your Trust.