Mdr / Vigilance Specialist

Sigmar Recruitment

Galway

MDR / Vigilance Specialist      What You Will Do: Complete complaint trend analysis and annual post market surveillance reports for various products. You will support risk management, risk analysis and health hazard analysis associated with complaint/post-market information. Drive continuous improvement activities to support the role out of cell operating systems and principles within the PXM department.  You will also support problem solving initiatives within the department and coach or mentor other team members. Scan the company's product 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. Review and analyze clinical databases for the extraction of data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of data 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.   What You Will Need: Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline and preferably with 2-3 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    To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@sigmar.ie   All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent.  .

1106 days ago