Aps Level 6

**Job Reference Number **22-MDPQDIV-14258
**Classification **APS Level 6
**Job Title **Medical Device Assessors (two positions)
**Division **Medical Devices and Product Quality Division
**Branch **Medical Devices Authorisation Branch
**Section **Device Applications Section
**Location **Fairbairn ACT
**Status **Ongoing
**Employment type **Full-time
**Salary Range **$88,439 - $99,772 per annum
**Mandatory Qualifications **Relevant qualifications in science or health related field of studies***
**Contact Officer Name**:Jane Shum
**Phone**:02 6289 2523

**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 pre-employment medical (where required).
Providing evidence of qualifications.

**Division Responsibilities**
The Medical Devices and Product Quality Division (MDPQD) is part of the Health Products Regulation
Group. The division ensures Australian and international therapeutic goods manufacturers and
products meet the highest standards for quality, safety and performance. MDPQD regulates the
quality of therapeutic products for the Australian community by:

- assessing medical devices, including in vitro diagnostic tests
- testing and monitoring medical devices and medicines to help ensure they continue to meet
- appropriate levels of quality, safety and performance- auditing and certifying manufacturers against manufacturing standards so the products they

produce meet appropriate quality, safety and performance standards.

**Branch Responsibilities**
The Medical Devices Branches evaluate medical devices, including in vitro diagnostic tests, and
monitors them throughout their lifecycle to ensure they continue to meet an appropriate level of
quality, safety and performance.

**Section Responsibilities**:
devices in the Australian Register of Therapeutic Goods (ARTG)****:

- The assessments include, among other things, assessment of technical information and data

against regulatory requirements and seeking and coordinating expert advice where required****:

- Contribute to standards development****:

- Contribute to internal and external guidance for sponsors and manufacturers of medical

devices and OTGs****:

- Represent the Department at cross-agency meetings and other forums****:

- Contribute to reform work to deliver and implement legislative changes.***

**Key Responsibilities**
Duties within this position are not limited to, but may include:

- Make decisions, with direction from more senior staff, on tasks/assignments with

considerable complexity and sensitivity
- Develop and manage complex relationships with internal and external stakeholders and

escalated enquiries/cases and issues.
- Ensure quality outputs for a team including the development of specialist, professional

and/or technical expertise
- Conduct regular quality assurance of work area processes and manage identified risks

procedures and guidelines to situations involving complexity and sensitivity which require
considerable interpretation and analysis

**Key Capabilities**:

- Excellent written and oral communication skills- Ability to provide expert advice and interpretation within technical or professional area,
- including preparing relevant strategic advice where appropriate- Ability to liaise with stakeholders to resolve assessments or make referrals and ensure
- appropriate outcomes- Reviews own performance and identifies opportunities for improvement.
- Make effective use of individual and team capabilities and take responsibility for work
- outcomes- Ensure quality outputs for self and team including the development of specialist,
- professional and/or technical expertise.- Conduct regular quality assurance of work processes and manage identified risks.
- Maintain a flexible attitude to focus on new priorities in accordance with the strategic

direction, understanding that priorities may change without notice.
- Set priorities for the work area, maintain team cohesion, and ensure quality of outputs for

the work area.
- Contribute to managing change and uncertainty in the workplace.***

**Desirable Experience**
Knowledge of the _Therapeutic Goods Act 1989_, the _Therapeutic Goods (Medical Devices) Regulations _
- 2002_ and other legislative instruments and guidelines

**Application Response**

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 statemen