Our client a leading medical device company in Galway are looking for an experienced Senior Engineering Supervisor to come onboard;
Responsibilities may include the following and other duties may be assigned;
- Supervision of complaint handling activities for a wide range of products and managing timely approval of regulatory reporting decisions.
- Timely submission of US Medical Device Report (MDR) and EU Vigilance Reports to external regulatory agencies.
- Supporting the coordination of cross functional responses to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports.
- Ensuring adequate support of complaint trend analysis and annual post market surveillance reports for various products.
- Supporting complaint handling harmonization initiatives with other Medtronic sites globally.
- Supporting risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
- Contributing 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.
- Supervising direct reports and managing their performance and supporting them to enable their development within the organization.
- Monitoring the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
- Ensuring complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
- Reviewing and analyzing clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
- Acting as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
KEY SKILLS & EXPERIENCE REQUIRED;
- We are looking for a person qualified to Third Level 8 Degree in Science, Engineering or related discipline and a minimum of 3 years relevant supervisory experience.
- Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered.
- Candidate must be a dynamic team player and leader and can work effectively and proactively on cross-functional teams
- Candidate must be able to think critically and make sound decisions and experience in Complaint handling or risk management would also be desirable.
- Candidate must be focused on patient safety and customer service, set high standards, instil operational excellence, drive accountability and model ethical behaviour
- Candidates must be a good communicator and fluent in English, both in writing and speaking.
For further information on this Senior Engineering Supervisor role in Galway please contact Anna McGowan on 086 4667369 / email@example.com
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