Aps Level 6

**Job Reference Number **22-MDPQDIV-14915

**Classification **APS Level 6

**Job Title **Project Officer

**Division **Medical Devices and Product Quality Division

**Branch **Medical Devices Surveillance Branch

**Section **Medical Device Vigilance and Policy Section

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

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$88,439 - $99,772

**Contact Officer Name**:Maria Ong
**Phone**:02 6289 1215

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

**Division Responsibilities**

Medical Devices and Product Quality Division (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.

**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 Medical Device Vigilance and Policy Section (MDVP) will enable proactive post-market

vigilance of medical devices and will complement and support recent medical devices

regulatory changes that enabled the acceptance of marketing approvals and certificates

from comparable overseas regulators as evidence. The MDVP includes (but is not limited

to):

- an audit program to verify sponsors are complying with conditions of inclusion in the

ARTG, including having an agreement with the manufacturer, appropriate collection of

distribution data, and recording of complaints, adverse events, and recall actions; and
- a virtual education program to assist the sponsors, whilst promoting best practice

regulatory compliance to ensure end user safety.

**Key Responsibilities**

Assist in developing protocols to implement the medical device vigilance pilot program. This

includes undertaking reviews and evaluating medical devices sponsors’ documentation and

other supporting material and inspecting sponsors premises, where required. Specific tasks

include:

- Assisting in implementing the pilot program and evaluation after 12 months.
- Provide input to and/or revise the draft sponsor survey tool.
- Develop and/or provide input to guidance material, education materials.
- Assist in developing and delivering information sessions on the MDVP
- Assist in developing templates for reporting and other protocols e.g standard operating

procedures.
- Assist in reviewing the sponsors’ vigilance assessment tool and evaluate sponsors for

further actions including desk top audits, seeking more information and on-site

inspections.
- Support and undertake pilot inspections and audits, this may include travel.
- Analyse and review sponsor provided information.
- Draft inspection outcome and other reports (close-out, six monthly or annual) as

required
- Where required review and summarise existing TGA regulations, the EU Medical Devices

Regulations, the US FDA provisions, practices of other comparable countries and other

existing practices (to inform ongoing refinement of the MDVP).
- Undertake research and work closely with the Director and other internal stakeholders

as required, on resolution of questions concerning issues arising out of the program and

the regulations.
- Draft meeting papers, briefing and organise meetings including with external

stakeholders as required.
- Provide other administrative support e.g., assist with project planning, reporting and

manag