Associate MDR Valiance Specialist
Responsibilities may include the following and other duties may be assigned.
- Responsible for the co-ordination of complaint handling activities for a wide range of products.
- Responsible for the 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 experiecne 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.