MDR Vigilance Specialist
MDR Vigilance Specialist (Medical Device Complaint Handling & Regulatory Reporting)
Our client is a well know Galway multinational with a new contract opportunity for a MDR Vigilance Specialist to join on an initial 12 month contract. This role is working within the Complaint Handling & Regulatory Reporting Department were you will focus on complaint handling and post market regulatory reporting activities. As the Vigilance Specialist, you will be part of a high performing team and be given extensive training on the products, Complaint Handling and Medical Device Regulatory reporting. This is a role where you will provide immense value through world class execution in Medical Device Reporting and Vigilance compliance.
- Co-ordination of complaint handling activities for a wide range of products including receipt and documenting of incoming complaint events.
- Support complaint trend analysis and issuance of key report to relevant departments.
- 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 product 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 analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database.
- Standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
- Co-ordination of cross-functional activities in the investigation of customer complaints and determination of root cause.
- Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
Education, Experience and Skills:
- Bachelor’s degree in Engineering/Science or related discipline.
- 1-3 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.
- Experience/understanding of complaint handling or CAPA processes are desirable.
- Team player who can work effectively and proactively on cross-functional teams as this role is working from home for the foreseeable future. Excellent training will be proved!
- Focus on patient safety and customer service, set high standards, instills operational excellence, drive accountability and model ethical behavior.
- Excellent communicator who is fluent in English, both in writing and speaking.
For further information on this MDR Vigilance Specialist role in Galway, please contact Marchon Monroe on 0860449473 / firstname.lastname@example.org
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