APS 6 Project Officer - SaMD

About the company

The Medical Devices Surveillance Branch is responsible for the post market activities of medical

devices, including Software as a Medical Device (SaMD) and in vitro diagnostic medical devices

(IVDs), and monitoring them throughout their lifecycle to ensure they continue to meet

appropriate standards.

About the opportunity

This role sits with the Devices Emerging Technology & Diagnostics Section. This section provides support in researching and keeping abreast of emerging medical device technology. The team works closely with assessment teams to share knowledge and information, to progress a number of specific reforms. They identify, educate and engage with relevant stakeholders and develop and review the regulations and guidance to ensure they are fit for purpose.

The APS6 Project Officer is responsible for providing input into SaMD related strategy, policies and reforms for the Medical Devices Surveillance Branch.

Duties

• Support the implementation of regulatory changes for the broader medical device reforms, following the TGA Regulation amendments.
• Contribute to the development and implementation of regulatory reforms in relation to SaMD medical devices including development of: policy documents for review and publication; consultation papers and analysis of results; and guidance material for industry.
• Respond to specific and complex email and phone enquiries from internal and externa Stakeholders.

• Research and write reports on specificed areas of medical device software products e. g. clinical decision support software

• Maintain key strategic relationships with a broad range of stakeholders, providing timely, quality and accurate advice on issues relating to medical device regulation and interpretation of legislation and guidelines.
• Contribute own expertise by providing technical input in preparation of ministerial briefs and involvement in other parliamentary support work as required.
• Assist in strategic planning, program and project management and/or policy development for the work area.

Mandatory Qualifications

• Bachelor's degree or equivalent experience in computer science, software engineering or related area
• Experience in a commercial or government IT software development environment.

Desired Qualifications

• Architecture, design, validation or project management of software builds would be highly regarded.
• Experience in commercial or medical software development.
• Experience in auditing or reviewing IT systems or products.

Position Capabilities

• Sound judgment, attention to detail and organisational skills and ability to take responsibility for work, prioritising tasks and producing quality outputs to meet tight deadlines.
• Proven ability to produce work requiring little or no revision before finalisation
• Excellent written and oral communication and interpersonal skills;
• Ability to engage and collaborate with stakeholders (both internal and external) and demonstrated ability to translate technical information for others using appropriate, unambiguous language.

How to Apply

Click apply or contact Joanna Murphy, Senior Recruitment Consultant on +61 2 8877 8718 for a confidential discussion.

( SK927795A )