APS 6 IVD Assessor

McArthur is working with a Federal Government Agency to source for APS 6 IVD Assessor based in Brisbane.

Your duties will include, but will not be limited to:-

• Conduct technical evaluations of in vitro diagnostic (IVD) medical devices and assist in the co-ordination of assessments requiring communication between various areas of the TGA
• Contribute to post-market reviews of existing ARTG entries for IVD medical devices
• Respond to specific and complex email and phone enquiries from internal and external stakeholder
• Contribute own expertise by providing technical input in preparation of ministerial briefs and involvement in other parliamentary support work as required
• Report to the Assistant Director and contribute to Section and Branch corporate management, planning and reporting processes.

To be considered for this role, you will:-

• Have pathology laboratory, biomedical science or IVD industry knowledge or experience in a field relevant to the assessment of IVD medical devices, preferably in the areas of infectious diseases (including COVID-19), point-of care, serology or molecular diagnostics and with knowledge of ISO13485-certified quality management systems.
• Ability to undertake technical and regulatory assessments for IVD medical devices and to prepare technical reports of findings.
• Have an understanding of the Australian regulatory requirements for IVD medical devices or the ability to quickly develop this understanding

Mandatory Requirements:

• Must be an Australian Citizen
• Have an AFP National Police Certificate which is no greater than 12 months old

This is am ASAP start, so do not delay...APPLY NOW!!!