APS Level 6 - Compliance Evaluator - Listing Compliance Section

Australian Department of Health Disability & Ageing – Melbourne VIC

Investigate emerging safety and compliance issues relating to listed medicines, assess complex scientific and regulatory evidence, and contribute to risk-based compliance and enforcement action.

Investigate emerging safety and compliance issues relating to listed medicines, assess complex scientific and regulatory evidence, and contribute to risk-based compliance and enforcement action.

The key duties of the position include:

Key responsibilities:

- Triaging and risk assessing complaints, referrals, intelligence, safety signals and other potential non-compliance.
- Independently managing moderately complex compliance investigations, including gathering and critically evaluating scientific, clinical and regulatory evidence.
- Interpreting therapeutic goods legislation, standards and guidelines and developing timely, evidence-based recommendations for appropriate compliance or enforcement action.
- Managing competing priorities and engaging with internal and external stakeholders to progress emerging and high-priority matters.

Key capabilities:

- Strong critical thinking, research and analytical skills, with the ability to assess complex information and develop sound, evidence-based recommendations.
- Demonstrated expertise in regulatory compliance and enforcement.
- Comprehensive understanding of therapeutic goods regulation and associated legislative, policy and governance frameworks.
- Extensive experience assessing medicine and therapeutic good safety, quality and efficacy,



including the interpretation of clinical and scientific evidence to inform risk-based regulatory decisions.
- Highly developed analytical and investigative skills, with the ability to identify, assess and respond to compliance, safety and regulatory signals.
- Robust written and verbal communication skills, with the ability to clearly communicate complex regulatory, scientific and technical matters.
- Demonstrated ability to exercise sound judgement and problem solve, including making risk-based recommendations in complex or uncertain circumstances.
- Demonstrated ability to work under limited direction, manage competing priorities and collaborate effectively with internal and external stakeholders.

Eligibility

- To be eligible for employment with the Department of Health, Disability and Ageing, 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 (where required), and




- Obtaining and maintaining a security clearance at the required level.

- To be eligible for the role, applicants must hold a formal qualification in health, medicine, science, science/law or any other relevant discipline from an Australian tertiary institution or comparable overseas qualification.

Notes

- Applications close 11:30pm AEDT.
- Applicants are asked to quote reference number 26-MRDIV-32313 to assist when making an enquiry.
- This recruitment process is being used to fill both ongoing and non-ongoing positions. Non-ongoing positions will be offered on a specified term basis for an initial period of up to 12 months with the possibility of being extended (this will not exceed a total of 24 months in the same or similar role).

Getting to know the Department of Health, Disability and Ageing

The Department of Health, Disability and Ageing is focused on achieving better health and wellbeing for all Australians. If you would like to join our team, and can meet our job requirements, we invite you to apply for a position with us to build better health, better care and better quality for all Australians. The department is committed to providing an inclusive and diverse workplace where the experiences, skills and perspectives of all individuals are valued. We actively encourage applications from diverse backgrounds and cultures, so we can better represent the community we serve. The department welcomes applications from Aboriginal and Torres Strait Islander people, people with disability, mature age people, people who identify as LGBTI+, an

📌 APS Level 6 (Australia)
🏢 Australian Department of Health Disability & Ageing
📍 Australia