Aps Level 6

2 weeks ago

Canberra, ACT, Australia National Health Funding Body Full time

Job Reference Number 23-MDPQDIV-19143

Classification APS Level 6

Job Title Program/Reform Officers (Several Positions)

Division Medical Devices and Product Quality Division

Branch Medical Devices Surveillance Branch; Medical Devices
Authorisation Branch

Section Various Sections

Location Fairbairn, ACT; Sydney, NSW; Melbourne, VIC; Brisbane, QLD

Status Ongoing

Employment type Full-time

Salary Range $91,092 to $102,765

Security Clearance Ability to acquire or maintain baseline security clearance

Desirable Qualifications A relevant qualification in any relevant discipline from an
Australian tertiary institution or comparable overseas
qualification

Contact Officer Name:
Pierre Nijssen

Phone:

Anticipated timeline for Recruitment

Milestone Date(s)
Applications open Monday, 31 July 2023

Applications close Sunday, 13 August 2023

Application shortlisting Thursday, 10 August 2023

Interviews** Week Commencing 17 August 2023

Reference checks Following interviews

Selection report finalisation Week Commencing 7 September 2023

Offers and announcements By 1 October 2023

Eligibility

  • To be eligible for employment with the Department of Health and Aged Care
applicants must be an Australian citizen at the time an offer of employment is made

  • An applicant's suitability for employment with Health will also be assessed through a

variety of pre-employment check processes, such as:

  • Satisfactory completion of an Australian Federal Police criminal history check,
and where relevant a Working with Children and Vulnerable People Check.

  • Completion of a medical declaration and preemployment medical (where
required).

  • Providing evidence of qualifications.

Division Responsibilities
Medical Devices & Product Quality Division (MDPQD) contributes to the vision of the Health
Products Regulation Group (HPRG) 'Better health and wellbeing for all Australians through
regulatory excellence' and the wider Department 'Better health and wellbeing for all
Australians now and for future generations'. We ensure domestic and internationally
manufactured therapeutic products including medical devices, medicines and biologicals
supplied in Australia meet the highest standards for quality, safety and performance.

MDPQD undertakes a wide range of regulatory activities including assessing medical
devices, including in vitro diagnostic tests; laboratory testing and monitoring; inspecting,
auditing and certifying manufacturers against manufacturing standards to ensure the
products they manufacture meet appropriate quality, safety and performance standards;
and post market monitoring and coordination of recall actions for therapeutic goods when
issues arise. We also support Pacific Nations with medicines testing capability and
participate in a wide range of international regulatory forums.

Branch Responsibilities
The Medical Devices Surveillance Branch contributes to the vision of the Health Products
Regulation Group (HPRG) and wider Department 'Better health and wellbeing for all
Australians now and for future generations' through monitoring medical devices, including
in vitro diagnostic tests (IVDs) and other therapeutic goods (OTGs), throughout their
lifecycle to ensure they continue to meet an appropriate level of quality, safety, and
performance. The Branch undertakes complex monitoring, analysis investigation and review
activities for post-market regulatory monitoring and reforms; and keeps abreast of
emerging technology and adoption in medical devices and monitoring against the necessary
regulatory framework.

The Medical Devices Authorisation Branch is responsible for evaluating medical devices,
including in vitro diagnostic tests (IVDs) and other therapeutic goods, to ensure they meet
an appropriate level of quality, safety and performance.

Section Responsibilities
There are multiple positions across the sections listed below.

Devices Business Support Section (DBSS)
The Devices Business Support Section is responsible for provision of business support to the
two Medical Device Branches, including recruitment and procurement services, the
updating of web content, management of the medical devices' information line and
coordination requests. It is also the Secretariat for the program's advisory and industry
liaison committees.

Medical Devices Reform and IT Transformation Coordination Unit
The Medical Devices Reform and IT Transformation Coordination Unit provides direct
support to HPRG Senior Executives and Directors by planning, reporting, and monitoring
Medical Device Reform (MDR) and Medical Device Program (MDP) Projects. MDRITTCU also
provides a front door service for MDAB and MDSB for engagement with the IT Division and
HPRG Transformation on MDR IT related matters.

Devices Quality Audits and Assessments Section
The TGA Medical Devices Auditors undertake assessment of manufacturers of medi

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