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Assoc MDR/Vigilance Specialist

Reference:JSC0007388
Location: Galway
Qualification:Degree
Experience:See description
Job Type:Fixed Term Contract
Salary:Not Disclosed
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May be suitable for: Sales And Marketing Manager

We’re currently recruiting for an exciting opportunity with an award-winning medical device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

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.

Responsibilities

Responsible for the co-ordination of complaint handling activities for a wide range of 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 pronciples within the CQXM department.

Key skills and experience:

Qualified person to bachelor's degree (Level 8 NFQ) in Engineering/ Science or related discipline.

Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered. 1-2 years relevant experience in a medical devices or related environment.

Dynamic team player who can work effectively and proactively on cross functional teams. Ability to think critically and make sound decisions.

Must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour.

Good communicator and fluent in English, both in writing and speaking.



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