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IVD Assessors – Multiple positions/Multiple Locations – ACT/NSW/VIC/QLD

In Vitro Device Assessors(IVD Assessor) 
 
Number Of Positions – 3

Start Date – ASAP

Location – Canberra ACT, Brisbane QLD, Sydney NSW, Melbourne VIC

Length of Contract – 12 months

Hours – Full time 
 
Position Description

Our client is looking for several IVD Assessors to conduct technical evaluations of in vitro diagnostic (IVD) medical devices and assist in the co-ordination of assessments requiring communication between various areas within the department. Other duties include: 

  • 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 stakeholders
  • 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. 

Additional Requirements

  • 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

If interested, please apply directly through the links provided. Alternately, contact Kalpana Palaniyappa for more information.

Kalpana Palaniyappa
0403 200 666  
kalpana.palaniyappa@calleo.com.au 

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