At our Product Experience Management (PXM) group, which is part of the Galway PXM Complaint Handling and Regulatory Reporting Department we focus on complaint handling and post market regulatory reporting activities for a wide range of the Clients products. 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 an d Vigilance compliance.
- Co-ordination of complaint handling activities for a wide range of the Clients products including receipt and documenting of incoming complaint events.
- Co-ordination of cross-functional activities in the investigation of customer complaints and determination of root cause.
- Support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports. You will also support complaint trend analysis and issuance of key report to relevant departments.
- 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
- 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.
- Ensure 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.
- Review and analyse 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.
- Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
- We are looking for a qualified person with Bachelor's degree (Level8 NFQ) in Engineering/Science or related discipline and preferably with 1 -2 years relevant experience in a medical devices or related environment. Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered.
- We are looking for a dynamic team player who can work effectively and proactively on cross-functional teams.
- Experience/understanding of complaint handling or CAPA processes are desirable. Candidates must be able to think critically and make sound decisions.
- Candidates must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behavior.
- Candidates must be a good communicator and are fluent in English, both in writing and speaking.