Executive Level 2

**Job Reference Number **22-MDPQDIV-15460

**Classification **Executive Level 2

**Job Title **Professional Officer

**Division **Medical Devices and Product Quality Division

**Branch **Medical Devices Surveillance Branch

**Section **The Devices Emerging Technology and Diagnostics Section

**Location **Fairbairn, ACT

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$129,665 - $153,516

**Security Clearance **Baseline (Protected, Highly Protected, Restricted, Confidential)***

**Desirable Qualifications **Relevant qualifications in a science or health related field of
study and demonstrated ability to translate technical
information for others, focusing on key points and using
appropriate, unambiguous language.

**Contact Officer Name**:Kate McCauley
**Phone**:02 6289 8713

**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) 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 Surveillance Branch contributes to the vision of the Health Products

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

Australians 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.

**Section Responsibilities**

The Devices Emerging Technology & Diagnostics Section (DETDS) provides support in

researching and keeping abreast of emerging medical device technology. The section is

involved the development of new policy related to the regulation of emerging technology,

reviewing the regulations to ensure they are fit for purpose, education of industry and

ongoing engagement with relevant stakeholders. DETDS works closely with assessment

teams to share knowledge and information and internationally through the International

Medical Device Regulator Forum and other forums to support alignment.

**Key Responsibilities**
- Provide expert advice to the internal stakeholders, manufacturers, and other

external stakeholders, relevant to the design, development and manufacture of

emerging technology including software-based medical devices and personalised

medical devices (e.g., 3D printed devices)
- Oversee the development of guidance and technical material relating to emerging

technology, particularly digital health technology, and the regulation of digital health

products and other medical devices
- Assist in the implementation of regulatory changes for the broader medical device

reforms, following the TGA Regulation amendments***
- Develop and manage key strategic relationships with a broad range of stakeholders,

providing timely, quality, and accurate advice on issues relating to emerging

technology***
- Represent the TGA on relevant national and international forums, committees and

working groups Mentor and develop expertise of medical devices staff***

**Key Capabilities**
- A high degree of knowledge and experience in a field related to emerging technology

and medical devices (e.g., software-based medical devices, artificial intelligence, 3D

printing)
- Ability to develop and interpret policy in a specialised area of work that requires

extensive understanding of the industry and international activities
- Ability to prepare, review and advise on policy reports, briefing papers, speeches,

Ministerial correspondence, and consultation papers for presentation to external

stakeholders and senior internal staff
- Ability to engage with and manage stakeholders (both internal and external).

**Minimum Requirements**

RecruitAbility is a scheme which aims to attract and develop applicants with disability and

also facilitate cultural changes in select