el1 medical device assessment team leader in Canberra

posted
contact
taylor dudley, randstad
job type
permanent

job details

posted
location
canberra, australian capital territory
specialism
government & defence
job type
permanent
working hours
Full-Time
reference number
90M0434323_1609722917
contact
taylor dudley, randstad
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job description

Randstad is exclusively working with the Theraputic Goods Administration to support their recruitment processes in the Medical Devices Branch. Please follow the link at the bottom of the page to lodge your application directly with the Department.

About the Health Products Regulation Group

Regulation that protects and enhances the health and safety of the community is a major component of a high quality health system. The Health Products Regulation Group supports timely access to products that will help achieve better health and wellbeing, whilst checking that these products do not themselves put Australians' health and safety at risk. We achieve this through regulation of therapeutic goods and certain controlled drugs and drug substances. This applies to all such goods exported, imported, supplied and manufactured in Australia.

The Opportunity

Medical Device Assessment Team Leaders EL1 – (several positions, across two sections) (Ongoing, Non-ongoing, Fulltime, Part-Time).

Positions available

Team Leaders in the Devices Conformity Assessment Section and the Devices Application Section are responsible for leading and managing a team of assessors, undertaking regulatory and technical assessment of applications for medical devices (including IVDs) and other therapeutic goods (OTGs), through the evaluation of technical documentation and data; and documenting results in clearly articulated technical reports.

Devices Conformity Assessment Section

Devices Conformity Assessment Section is a large and diverse section of technical specialists responsible for pre-market conformity assessment certification of manufacturers of medical devices and In-Vitro Diagnostics (IVDs). This includes conducting design examinations for high risk medical devices, especially those incorporating medicines, animal origin materials, or IVDs. The section also works closely with specialists in a range of areas including clinical, sterility, and Quality Management Systems (QMS) in relation to the regulation of medical devices. The section is responsible for several major reform and business improvement projects.

Devices Application Section

The section is responsible for pre-market assessment of applications for inclusion of medical devices (including IVDs) in the Australian Register of Therapeutic Goods (ARTG), applications for variation, as well as assessing applications for listing of other therapeutic goods (OTG) (e.g. disinfectants).

Skills Required

For roles in the Devices Conformity Assessment Section (only), a relevant engineering, biotechnology or biological science degree (e.g. molecular biology, immunology, medical science) from an Australian tertiary institute or equivalent overseas qualification, with at least 3 years of professional practice in engineering, biotechnology, biological science or pathology. Candidates with software engineering qualifications or demonstrated relevant experience in relation to software and/or control systems for medical devices are encouraged to apply.

For roles in the Devices Conformity Assessment Section, preferably candidates will have postgraduate qualifications or experience in relevant fields such as engineering (preferably biomedical), biological or medical science, toxicology or In-Vitro Diagnostics.

Duties within these positions are not limited to, but may include:

  • Conducting detailed technical assessment of applications for Conformity Assessment related to high risk medical devices.
  • Engaging with industry on high risk medical device applications and related matters such as testing standards, application processing, and reform projects.
  • Developing and implementing business improvements to apply risk based assessment principles, reduce application processing timeframes, and improve clarity for industry regarding applications.
  • Continual improvement of reporting, data capture and analysis, knowledge management and professional skills in the section.
  • Providing timely, professional and accurate advice on issues relating to medical devices regulation, interpretation of legislation, guidelines, best-practice, emerging technologies, and fields of expertise (biomedical engineering, microbiology, biochemistry, chemistry or molecular biology/genetics)
  • Providing leadership, mentoring and guidance in technical and regulatory matters to achieve branch objectives
  • Managing workload including prioritisation, assignment of tasks, and maintaining statistics and records for reporting purposes. Managing and evaluation of high risk medical devices conformity assessment applications with considerable complexity and/or sensitivity using good judgement and expertise, and ensuring these recommendations are governed by the application of the Australian therapeutic goods regulatory framework and state of the art technical standards or other best-practice guidelines
  • Reviewing and approving technical assessment reports
  • Contributing to project work relevant to medical device regulation and reform, including proposing and facilitating innovation initiatives, regulatory reform, contributing to business improvement activities
  • Managing record keeping in accordance with the regulatory and legislative requirements and whole of- government policy and standards
  • Implementing change and managing ambiguity in the workplace
  • Contributing to a positive, collaborative and diverse workplace culture in line with the APS Code of Conduct and iCare Values.

Please note, these vacancies will be open for applications until Monday 11 January 2021 and interviews will be held in early 2021.

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.

Eligibility

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).
  • For these vacancies applicants must be able to obtain and maintain a Baseline security clearance, or hold a current security clearance of an appropriate level.

For further enquiries about these vacancies please contact:

Taylor Dudley - Scribing and Campaign Manager, Federal Government

02 6132 3816 | Taylor.Dudley@randstad.com.au

Please submit your application directly with the Department. Randstad are not accepting applications directly but are the main point of contact for any questions or queries with regards to this process. Copy and paste the below link into your browser to apply!

shorturl.at/gxzR6

At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.

skills

assessment, investigations, team leader, applications assessing

qualification

relevant qualifications

educational requirements

Associate Degree/Diploma