el1 in-vitro diagnostics (ivd) reforms project lead 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
90M0434317_1609720278
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

In-Vitro Diagnostics (IVD) Reforms Project Lead EL1 – (Ongoing, Non-ongoing, Fulltime, Part-Time)

The Project Lead works under limited direction, manages a small team within the Devices Emerging Technology and Diagnostics Section, and is responsible for undertaking regulatory reform work, with a current primary focus on IVDs.

Devices Emerging Technology and Diagnostics Section

The Section provides support in researching and keeping abreast of emerging medical device technology. The team works closely with assessment teams to share knowledge and information, is progressing a number of specific reforms related to in-vitro devices and emerging technology (such as software and personalised medical devices), identifies, educates and engages with relevant stakeholders and develops and reviews the regulations and guidance to ensure they are fit for purpose.

Skills Required

Duties within this position are not limited to, but may include:

  • Undertaking specialist or technical research and analysis activities related to the regulation of IVDs and exercising delegation as required
  • Taking the lead and responsibility for the management and progression of IVD-specific reforms, particularly the EU IVDR alignment work.
  • Engaging and collaborating with key IVD stakeholders both internally and externally to identify opportunities to facilitate cooperation.
  • Providing expert advice on policy, complex problem solving and issues management for internal and external IVD stakeholders
  • Supervising and managing the IVD Reforms team within the Devices Emerging Technology and Diagnostic Section
  • Drafting complex documents including consultation papers, regulatory impact statements and guidance material
  • Providing timely, professional and accurate advice on issues relating to IVD regulation,
  • 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 this role 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/sIW27

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

IVD, project lead, project management

qualification

Relevant Qualifications

educational requirements

Associate Degree/Diploma