Aps Level 4

**Job Reference Number **22-MDPQDIV-14816

**Classification **APS Level 4

**Job Title **Administrative Officer

**Division **Medical Devices and Product Quality Division

**Branch **Medical Devices Authorisation Branch

**Section **Devices Applications Section

**Location **Fairbairn, ACT

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$73,706 - $77,879

**Contact Officer Name**:Ben Todd
**Phone**:(02) 5156 6548

**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.

**Division Responsibilities**

The Medical Devices and Product Quality Division (MDPQD) regulates the quality of health

products for the Australian community by: assessing medical devices, including in vitro

diagnostic tests; testing and monitoring medical devices and medicines; and auditing and

certifying manufacturers against manufacturing standards so the products they produce

meet appropriate quality, safety and performance standards.

**Branch Responsibilities**

The Medical Devices Authorisation Branch (MDAB) contributes to the vision of the Health

Products Regulation Group (HPRG) and wider Department ‘Better health and wellbeing for

assessment and approval of medical devices for supply in Australia to ensure these devices

meet Australian regulatory requirements. The assessment of the quality, safety and

performance of medical devices including in vitro medical devices protects the health and

safety of the Australian consumers.

**Section Responsibilities**

The Devices Applications Section (DAS) is responsible for pre-market assessment of

(disinfectants). As part of these assessments, the section conducts audits that includes

assessment of the technical information and data against regulatory requirements and

seeking and coordinating expert advice where required. DAS also makes decisions on the

inclusion of devices and listing of other therapeutic goods in the ARTG and/or variation of

the ARTG entries for medical devices and other therapeutic goods. Further responsibilities

of the section include contribution to and implementation of regulatory reforms and

providing advice on the regulatory issues.

**Key Responsibilities**

The APS4 Administrative Officer works under general direction and undertakes specialist,

procedural, clerical, administrative support or operational tasks, including some research

and analysis activities, to support a team of medical device assessors. Duties within this

position are not limited, but may include:

- Make decisions with some autonomy that relate to role and area of speciality.
- Liaising with internal and external stakeholders on administrative and operational

matters.

stakeholder problems and provide assistance as appropriate.
- Undertake Freedom of Information (FOI) requests.
- Review manufacturers’ evidence.
- Performing research and analysis activities.
- Providing assistance to medical device assessors where required.
- Providing advice and education to stakeholders within constraints of policy.
- Provide quality assurance on reconciling payments and invoices.***

**Key Capabilities**
- Ability to research and analyse legislation and regulatory guidelines and make

recommendations based on evidence.
- Ability to supervise lower classification levels, including monitoring work practices,

set priorities within the work area, and develop local procedures.
- Ability to resolve moderately complex enquiries from stakeholders and provide

information and advice as a representative of the work area.

**Essential Requirements**

Essential requirements for this role include:

- Make decisions with some autonomy that relate to role and area of speciality.
- Liaising with internal and external stakeholders on administrative and operational

matters.
- Review manufacturers’ evidence.
- Providing assistance to medical device assessors where required.
- Providing advice and education to stakeholders within constraints of policy.***

**Desirable Experience**
- Experience in administrative work, use of Microsoft and Excel products, and ability to

learn medical terminology.
- Knowledge of the Therapeutic Goods Act 1989, the Therapeutic Goods (Medical

Devices) Regulations 2002 and other legislative instruments and guidelines.

the real potential to develop, the required skills, knowledge, experience and qualifications

to perform the role. These requirements are based on the information provided to you as

part of the job advertisement, in line with the APS Work Level Standards.

Applicants are required to provide a statement of claims framed around t