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January

Project Officer

First Grade Group - Canberra Airport, ACT

Government, Defence & Emergency
Source: uWorkin

Source: uWorkin

JOB DESCRIPTION

Tuesday, January 26, 2021
Location: ACT
Job Type: Contract or Temp
Reference No. 3211313

Job Description:
Location of work: Canberra, ACT
Proposed contract start date: 15/02/2021
Contract duration: 12 months with extensions

Section Responsibilities

The 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, is progressing a number of specific reforms related to in-vitro medical devices and emerging technology, (such as software and personalised medical devices), identifies, educates and engages with relevant stakeholders and develops and reviews the regulations and guidance to ensure they are fit for purpose.

Branch Responsibilities

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 Position

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

Key duties:
Under limited direction, 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 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.
Capabilities, Skills and Qualifications

Mandatory Qualifications:
Bachelors degree or equivalent experience in computer science, software engineering or related area; and
Experience in a commercial or government IT software development environment.

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
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.

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.

About First Grade Recruitment:
We are one of Australia's leading Indigenous owned and Supply Nation certified consultancies, with long-standing clients across Federal, State and Local Government, and the Private Sector.

We're committed to building a diverse and inclusive workforce and we encourage applications from people of all cultures and backgrounds.

We look forward to receiving your application!

Canberra Airport, ACT

Government, Defence & Emergency




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