Associate MDR/Vigilance Specialist

Desired Skills: MS Office Suite,Medical Device,Medical Reporting,Science,Engineering

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 aisling.oleary@peglobal.net

****Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****