Telephone: 086 8395533
Engineering Supervisor - Complaint Handling and Regulatory Reporting Department
Our client, a medical device company in Galway are currently looking to recruit an Engineering Supervisor for their site.
- You will be responsible for the supervision of complaint handling activities for a wide range of products. You will be responsible for managing timely approval of regulatory reporting decisions.
- You will also be responsible for the timely submission of US Medical Device Report (MDR) and EU Vigilance Reports to external regulatory agencies.
- You will also support the coordination of cross functional responses to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports.
- You will also ensure adequate support of complaint trend analysis and annual post market surveillance reports for various products.
- You will also support complaint handling harmonization initiatives with other sites globally.
- You will support risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
- You will contribute to continuous improvement activities to support the role out of cell operating systems and principles within the PXM department.
- You will also lead critical problem solving initiatives within the department and coach or mentor other team members.
- You will supervise direct reports and manage their performance and support them to enable their development within the organization.
- We are looking for a qualified person to Third Level 8 Degree in a relevant Technical qualification and desirably with 5-8 years relevant experience or 3-6 years with a Masters qualification.
- You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams.
- Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered.
- People management or coaching experience is desirable.
- Candidates must be able to think critically and make sound decisions and experience in Complaint handling or risk management would also be desirable.
- Candidates must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour
- You are a good communicator and fluent in English, both in writing and speaking.
For further information on this Engineering Supervisor role in Galway please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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