Our Federal Government Client is seeking an APS6 Project Officer to provide input into SaMD related strategy, policies and reforms.
This is a contract role for 12 months, located at our Client's Canberra City location.
As the selected candidate, you will:
- Support the implementation of regulatory changes for the broader medical device reforms
- 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 external stakeholders
- Research and write reports on specified 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
- Prepare procedural or technical manuals and guidelines for clearance by senior employees
- Assist in strategic planning, program and project management and/or policy development for the work area
To be successful in this role, you should have:
- Experience in a commercial or government IT software development environment
- 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
- Maintains a flexible attitude, understanding that priorities may change without notice and able to focus on new priorities in accordance with the strategic direction
- The ability to understand detailed technical information and regulatory principles and summarise concisely at a high level
- The ability to understand principles and identify potential risks or issues that relate to safety and performance.
It is desirable if you have:
- Architecture, design, validation or project management of software builds would be highly regarded
- Experience in commercial or medical software development
Due to security clearance requirements for this role, candidates must be Australian Citizens who currently possess or are able to obtain Federal Government Security Clearances.
Apply now for immediate consideration - contact Carissa Burgos on 02 9137 8700 quoting Job Reference: #209118
Please note: Only candidates that meet the above criteria will be contacted. Thank you for your interest in the position.
