Regulatory Affairs (Senior) Specialist Jobs in Rowville, Australia

Universal Biosensors (UBI) is a world leading, publicly listed Australian company (ASX:UBI) which develops, manufactures and sells biosensors for use in several industries around the world. Our biosensor technology has been used in more than 10 billion measurements for blood glucose monitoring and blood coagulation in diabetes and coagulation patients worldwide. More recently, we have pivoted our technology into non-medical products, including SENTIA for the global wine industry and Petrackr for the veterinary domain. In addition, we continue to develop new applications for our technology within human health with the imminent US launch for the next generation of coagulation monitoring device, Xprecia Prime, in 2023. Prime is already available for sale in EU!We are looking for a focused and driven individual to assist our Regulatory amp; Clinical Manager (in our Melbourne office) as a Regulatory Senior Specialist as we prepare for various regulatory submissions related to our Xprecia Prime product approval. The role will consist of (but not limited to) the following activities:-Prepare Medical Device Files for submission to regulatory authorities across the globeMaintain Medial Device Files and other regulatory documentationMaintain regulatory license databases and systems which contain regulatory approval or restriction informationCommunicate with regulatory agencies and conformity assessment bodiesProvide regulatory support to existing projects, as necessaryPerform administrative tasks, including document formatting, and preparing documentation.Provide input on PMS, including alignment to FDA, TGA and EU IVDR requirementsAssist coordinating Post-Market Surveillance activities

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