Aps Level 5

3 weeks ago

Melbourne, Australia National Health Funding Body Full time

**Job Reference Number **23-MDPQDIV-17220

**Classification **APS Level 5

**Job Title **Review Coordinator

**Division **Medical Devices and Product Quality Division

**Branch **Medical Devices Surveillance Branch

**Section **Device Post Market Reforms and Reviews Section

**Applications open date **Wednesday, 12 April 2023

**Applications closing date **Wednesday, 26 April 2023 at 1130pm AEST

**Location **Melbourne VIC, Fairbairn ACT, Parramatta NSW

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$81,372 - $88,000

**Contact Officer Name**:Amanda Craig
**Phone**:02 62891086

**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 a 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**

MDPQD 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; and
- auditing and certifying manufacturers against manufacturing standards so the

products they produce meet appropriate quality, safety, and performance standards.

We undertake monitoring, investigation and review activities for post market regulatory

monitoring and reforms and remain abreast of emerging technology and adoption in

medical devices and monitoring against regulatory frameworks. We monitor medical

devices, including in vitro diagnostic tests (IVDs) and other therapeutic goods (OTGs),

throughout their lifecycle to ensure they continue to meet appropriate levels of quality,

safety, and performance.

**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 Device Post Market Reforms and Reviews Section (DPMRRS) within the Medical Devices

Surveillance Branch is responsible complex monitoring, analysis, and review activities for

post market regulatory programs for medical devices. The section is also responsible for the

development and implementation of post-market reforms for medical device regulation and

business processes.***

**Key Responsibilities**

The APS5 Review Coordinator is responsible for
- co-ordinating communications and submissions in relation to post-market

surveillance activities of the TGA.***
- providing secretariat support for working groups***
- Input of signals for potential post-market reviews of medical devices into the review

database.
- Collating and coordinating responses to requests under the Freedom of Information

Act.
- Drafting and reviewing operating procedures and guidance documents.
- Performing general administrative duties as required.

stakeholders about post-market reviews.
- Requesting information and samples from sponsors and manufacturers during the

investigation/review process.
- Participation in the implementation of the TGA’s reform work.
- Assistance under supervision in preparation of ministerial briefs, other parliamentary

work, along with written and verbal advice to external stakeholders.
- Represent the TGA at various internal and external meetings.

**Key Capabilities**
- Sound judgment, attention to detail, organisational skills and ability to take

responsibility for work, prioritising tasks, and producing quality outputs to meet tight

deadlines.
- Maintains a flexible attitude, understanding that priorities may change without

notice and able to focus on new priorities in accordance with the strategic direction.

priorities, practices, and methodologies to deliver quality outcomes.

**Minimum Requirements**

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

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