The Role
PE Global are recruiting for an
Associate MDR/Vigilance Specialist
for our medical device client based in Galway.
This is a 24-month contract role.
Hybrid working options.
Job Responsibilities
Responsible for the co-ordination of complaint handling activities for a wide range of products, but more specifically pacemaker products.
Responsible for 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.
Education & Experience
Bachelor's degree (Level 8 NFQ) in Engineering/ Science/ Legal/ Clinical or related discipline.
1-2 years relevant experience in a medical devices or related environment preferred.
Dynamic team player who can work effectively and proactively on cross functional teams.
Ability to think critically and make sound decisions.
Strong attention to detail
Knowledge of basic anatomy, physiology, and medical terminology
Must be focused on patient safety and customer service, set high standards, instill operational excellence, drive accountability and model ethical behaviour.
Good communicator and fluent in English, both in writing and speaking
Interested candidates should submit an updated CV.
Please click the link below to apply, alternatively send an up-to-date CV
****Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****