- To be eligible for employment with the Department of Health 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.
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 the appropriate quality, safety and performance standards.
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
Devices Post Market Monitoring undertakes risk assessments of all reports entered into the Incident Report Investigation Scheme (IRIS) database and conducts in-depth investigations if necessary. It also reviews, using a risk-based approach, issues with medical devices based on signals from many sources such as reports in the IRIS database, information from other regulators, an unresolved or increasing number of recalls, government and publications in journals or newspapers. The section also reviews information provided on an annual basis
by sponsors of medical devices that are Active Implantable Medical Devices (AIMD), Class III and implantable Class IIb; and information related to the close-out of recall actions. The section also provides advice to government, industry, consumers and media.
The APS5 Investigator is responsible for undertaking risk assessment and investigation of adverse event reports associated with the use of medical devices.
- Duties within this position are not limited to, but may include:
- Providing detailed technical engineering/biocompatibility or clinical expertise in the area of medical device technology, including anticipating problems and contributing to issues management;
- Implementing a risk management approach to support regulatory decisions;
- Dealing with less complex issues and managing stakeholders;
- Providing timely, quality and accurate advice on issues relating to medical device
regulation and interpretation of legislation and guidelines in a particular area of expertise and knowledge;
- Managing record keeping in accordance with the regulatory requirements and whole of- government policy and standards;
- Writing statements for publication on the safety and performance of medical devices on TGA’s website;
- Contributing to the development and revision of technical and administrative procedures and documentation within the Branch;
- Communicating with relevant stakeholders, including providing advice and feedback on the outcomes of investigations;
- Undertaking an assessment of the technical documentation and data, collating expert advice relevant to the assessment, preparing a clear statement of reasons based on the investigation findings and knowledge of the regulations, and exercising delegation where appropriate;
- Contributing to a positive, collaborative and diverse workplace culture in line with
the APS Code of Conduct and iCare Values.Key Capabilities
• Ability to interpret, draft and review policy and procedural documentation;
- Maintain knowledge of relevant legislative and reporting requirements, Australian and International standards, quality assurance procedures and best practice models;
- Ability to apply comprehensive work knowledge, precedent and established legislation, policy, procedures and guidelines to situations involving a high level of complexity and sensitivity which require considerable interpretation and analysis;
- Strong communication skills including the ability to prepare clearly articulated reports and briefs on the subject matter;
- Technical expertise and experience relevant to the use, assessment, manufacture, design, testing and monitoring of medical devices.Desirable Experience
- Knowledge of the Therapeutic Goods Act 1989, the Therapeutic Goods (Medical Devices) Regulations 2002 and other legislative instruments and guidelines.
- Experience in regulatory and technical assessments and reporting through evaluation of technical documentation and data in the field of medical devices will be highly regarded.
Working in the Medical Devices and Product Quality Division
Our people are committed, innovative, client-focused and collaborative. We are an inclusive workplace. We celebrate and champion diversity to reflect the community we serve. We are a flexible employer and are open to discussing employment arrangements that suit you best at this time.
Work within an environment that encourages participation, recognises the effort and works to build capability and expertise.
We seek people with a wide variety of skills and competencies and look for applicants who demonstrate they will strive to support the behaviours we seek to foster in our workforce.
We are an inclusive employer and promote, value and support diversity among our employees with the aim of ensuring our workforce reflects, respects and benefits from diverse communities including Indigenous Australians, people from culturally and linguistically diverse backgrounds, LGBTQI+ and people with disability.
RecruitAbility applies to this vacancy. Under the RecruitAbility scheme you will be invited to participate in further assessment activity for the vacancy if you choose to apply under the scheme; declare you have a disability, and meet the minimum requirements for the job. For
more information visit: https://www.apsc.gov.au/recruitability
Your application will be assessed on your ability to demonstrate that you possess, or have the real potential to develop, the required skills, knowledge, experience and qualifications to perform the role. These requirements are based on the information provided to you as
part of the job advertisement, in line with the APS Work Level Standards.
Applicants are required to provide a statement of claims framed around the key duties and key capabilities. Your statement of claims should be no more than one page in total with a font no smaller than size 10. Applications that do not meet these requirements may not
Work Environment Description
Responsibilities – As detailed in Section 28 of the Work Health and Safety Act 2011 while at work, a worker must:
- Take reasonable care for his or her own health and safety
- Take reasonable care that his or her acts or omissions do not adversely affect the
health and safety of other persons
- Comply, so far as the worker is reasonably able, with any reasonable instruction that
is given by the person conducting the business or undertaking to allow the person to comply with this Act
- Cooperate with any reasonable policy or procedure of the person conducting the
business or undertaking relating to health or safety at the workplace that has been notified to workers
- Complete all WHS related induction and training
- Report all work-related incidents and/or illnesses to the WHS Section
Description Requirement Additional Information
1. Computer Use Yes Desktop-based assessment work
2. Generic screen-based Yes
3. Sitting at desk Yes
4. Standing for long periods No
Description Requirement Additional Information
5. Lifting 0-15kg No
6. Lifting 15 kg + No
7. Climbing No
8. Bending No
9. Squatting No
10. Reaching No
11. Push/pull No
12. Sequential Repetitive No Movements in a short period of time
13. Manual dexterity/manipulation No
14. Work with others towards Yes - shared goals in a team environment
15. Works in isolation from other No staff (remote supervision)
16. Distance walking (ie: Large No building or inter-building transit)
17. Works outdoors No
18.Works in a call centre No environment
19. Works in a customer service No environment
20. Exposure to chemicals No
21. Exposure to biological hazards No
22. Working at heights No
23. Requirement to wear personal No protective equipment (PPE)
24. Requirement for full Colour No
Description Requirement Additional Information
25. Work with energetics and No explosives
26. Exposure to Petrol, Oil, Lubricant No Products that may cause dermatological conditions
27. Exposure to extreme No temperatures
28. Confined spaces No
29. Exposure to Non-ionising No
30. Excessive Noise No
31. Low Lighting No
32. Dangerous Goods/ Equipment No
33. Exposure to airborne odours No
34. Frequent travel - Vehicle No
35. Frequent travel - Aeroplane No
36. Frequent travel - Seaborne No
37. Peaks & Troughs No
38. Frequent Overtime No
39. Rostered Shift Work No