Overview
One of our Federal Government Clients are in the process of assessing Software as a Medical Device (SaMD) products and providing high level summaries and findings.

Due to the nature of the role, candidates must be Australian Citizens to be found suitable. 


Key Responsibilities     

• Assess information provided by software vendors or developers, highlighting gaps, issues and areas of risk.
• Research information about software products.
• Assess technical artefacts provided to identify whether they are fit for purpose, complete and technically sound.
• As part of the team, respond to specific and complex email and phone enquiries from internal and external stakeholders, seeking appropriate clearance where required.
• Research and write reports on specified areas of medical device software products.
• Contribute own expertise by providing technical input in preparation of reports and other policy implementation undertaken by the team  

• Experience in a commercial or government IT software development environment.
• Assesses technical artefacts to identify whether they are fit for purpose, complete and technically sound.
• Experience providing technical input for reporting and other policy implementation undertaken by the Section. 

• Undertakes assessment, research and analysis of information about software products from diverse sources and formulates conclusions in line with policy.
• Maintains familiarity with medical device regulations relating to software.

• Works autonomously or as part of a team, responding to specific and complex email and phone enquiries from internal and external stakeholders, seeking appropriate clearance where required.
• Demonstrated ability to translate technical information for others using appropriate, language.

• Canberra / Sydney / Melbourne / Brisbane offices 
• Hybrid and remote work available. 
• 12 month contract with extension options.