Aps Level 6

3 weeks ago

Canberra, Australia National Health Funding Body Full time

**Job Reference Number **23-MDPQDIV-18002

**Classification **APS Level 6

**Job Title **Regulatory Reforms Project Officer

**Division **Medical Devices and Product Quality Division

**Branch **Manufacturing Quality Branch

**Section **GMP Operations and Strategy Section

**Applications open date **Friday, 9 June 2023

**Applications closing date **Sunday, 2 July 2023

**Location **Fairbairn, ACT

**Status **Ongoing

**Employment type **Full-time

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

**Desirable Qualifications **A tertiary qualification in science such as chemistry,
biochemistry, microbiology, biotechnology, pharmacy or
engineering from an Australian tertiary institute or equivalent
overseas qualification.

**Contact Officer Name**:Katherine Clark
**Phone**:(02) 6289 3615

**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**

The Medical Devices and Product Quality Division (MDPQD) is responsible for undertaking
for supply in Australia. It is also responsible for the ongoing monitoring of medical devices to
ensure they meet the necessary standards throughout their lifecycle. The Division also
works to ensure Australian and international therapeutic goods manufacturers meet
specified standards and provide laboratory services.

**Branch Responsibilities**

The Manufacturing Quality Branch (MQB) assists in the timely supply of therapeutic goods,
ensuring they are of appropriate quality for their entire lifecycle. This primarily relies on
assessing manufacturers' compliance with Good Manufacturing Principles for medicines,
blood, tissues and cellular therapy products and conducting product recalls for all types of
therapeutic goods. MQB also has responsibility for TGO 93 and quality of medicinal cannabis
products.

**Section Responsibilities**

inspection coordination and GMP regulatory reforms. The section has teams responsible for
issuing GMP licences and certificates, investigating compliance signals and undertaking
enforcement actions. In addition, the section supports the branch by providing strategic and
operational support in relation to regulatory reforms, business planning and Ministerial and
departmental requests for information, systems, data analytics and performance reporting.

**Key Responsibilities**

Working with a high level of autonomy and as part of a team, the successful applicant will
contribute to the regulatory reform projects within MQB.

The key responsibilities are to:

- Undertake the planning, implementation and post-implementation review of

regulatory reforms (which may include legislative change) and business
improvement projects across the Group, Division and Branch. At the current time,
the main focus of the role will be on development and implementation of reforms to
the regulation products that are supplied as ‘unapproved goods’, including medicinal
cannabis and psilocybin.
- Engage with external stakeholders such as Government Departments, therapeutic

good sponsors, manufacturers of therapeutic goods, peak bodies, associations, and
consumer groups to assist in the successful delivery of projects
- Under limited supervision contribute to planning, coordination and/or conduct of:

- Ministerial briefs, materials for external and internal stakeholder meetings,

legislation and regulatory amendments, risk based business planning & reporting.
- Business projects identified in the branch business plan associated with regulation,

cultural improvement and people capability.
- Assisting in the identification and implementation of process improvements and

providing technical advice to a range of internal and external stakeholders.

**Key Capabilities
- Well-developed communication skills and an ability to manage relationships with a

diverse range of internal and external stakeholders to achieve work area goals.
- Strong problem-solving skills and the ability to respond to change in an efficient and

effective manner.
- High-level organisational and planning skills, including the ability to identify and pre
- empt impacts of scheduling changes.
- Experience in the conduct of business projects, including improvement/change

initiatives and strategies.

**Minimum Requirements**

RecruitAbility is a scheme which aims to attract and develop applicants with disability and
also facilitate cultural changes in selection panels and agency recruitment. All vacancies for
the Department of Health and Aged Care are advertised under the RecruitAbility Sche

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