Mdr Vigilance Specialist

SIGMAR RECRUITMENT

GALWAY

MDR Vigilance Specialist. Responsibilities. Manage complaints from a wide range of medical devices and act as secondary approval for regulatory reporting decisions. Assist in any queries received from regulatory bodies. Supporting trend analysis, post market surveillance activities and risk analysis with regards to complaints. Assist in continuous improvement projects for operating systems and post market surveillance. Monitor and help develop drug and medical device surveillance program in line with government and regulatory regulations. Ensure accurate reporting of MDR, ADE and any other required regulatory data. Act as liaison both internally and externally between regulatory bodies, vendors and other stakeholders. Requirements. Must have a level 8 degree in engineering and science with 2 to 3 years relevant experience in medical devices or a similarly highly regulated environment. Must have experience in complaint handling or CAPA process. Legal or clinical qualification will also be considered. To apply for this position please contact James Porter at Sigmar RecruitmentT: +353 91 455305E: jporter@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. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

1627 days ago