Assoc MDR/Vigilance Specialist
Job ID: JOB-13156
Job Title; Assoc. MDR/Vigilance Specialist
Location; Parkmore, Galway
Duration: 12 month contract
May include the following and other duties may be assigned;
- Responsible for the co-ordination of complaint handling activities for a wide range of the clients 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.
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 behavior.
- Good communicator and fluent in English, both in writing and speaking.
For further information on this role in Galway please contact Sinead Killalea on firstname.lastname@example.org or 086-1287246
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