aps6 medical device assessor 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
90M0434324_1609723531
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 Assessor APS6 – (several positions, across two sections) (Ongoing, Non-ongoing, Fulltime, Part-Time)

Opportunities exist for a medical device assessor at the APS6 level in the following roles:

  1. Applications assessment
  2. In-vitro diagnostics assessor
  3. Biomaterials assessor
  4. Engineering assessor

Devices Application Section

Vacancies in the Devices Application Section are for the applications assessment. The Section is responsible for pre-market assessment of applications for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG), applications for varying existing ARTG entries, as well assessing applications for listing of other therapeutic goods (OTG) (e.g. disinfectants). The Section also undertakes reform activities.

Devices Conformity Assessment Section

Vacancies in the Devices Conformity Assessment Section are in assessor roles in the following teams; Biomaterials, Engineering and In-vitro diagnostics. The section is responsible for premarket conformity assessment certification of manufacturers of medical devices. The section maintains engineering, biocompatibility and IVD expertise and coordinates the component assessments from different areas within the Group.

Skills Required

Mandatory skills, qualifications, and experience for vacancies in the Devices Conformity Assessment Section – assessor roles:

  • A relevant engineering, biotechnology or biological science degree (e.g. molecular biology, immunology, medical science) from an Australian tertiary institute or equivalent overseas qualification.
  • Candidates with software engineering qualifications or demonstrated relevant experience in relation to software and/or control systems for medical devices are encouraged to apply.



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

  • Undertake desk top regulatory and technical assessments of pre-market inclusion applications for medical devices and other therapeutic goods (OTGs) in the Australian Register of Therapeutic Goods (ARTG) (Devices Application Section),
  • Undertake desk top regulatory and technical assessments of pre-market applications for conformity assessment and post market monitoring of medical devices (including IVDs) and other therapeutic goods (OTG) on the ARTG (Devices Conformity Assessment Section).

Devices Application Section and Devices Conformity Assessment Section:

  • interpret and apply legislation, regulatory guidelines, international standards and best-practice, collating expert advice relevant to the assessment, preparing clear statements of reason based on the investigation findings, matters of fact, and knowledge of the regulations, and exercising delegation where appropriate
  • Provide timely technical/professional advice to internal and external stakeholders
  • Be responsible for record keeping and record management of official decisions and actions in accordance with the Department of Health’s record management protocols
  • Participate in providing quality improvement in regulatory processes and reform in key areas, according to government priorities
  • Positively contribute to representing the TGA at various internal and external meetings as necessary to fulfil the TGA’s functions as the national regulator of the therapeutic goods as required
  • Contribute to broaden organisational objectives by undertaking other tasks as required
  • Contribute to a positive, collaborative and diverse workplace culture in line with the APS Code of Conduct and iCare Values.

Please indicate which vacancies you wish to be considered for as part of your application.

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 roles 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/ftM38

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, applications assessing

qualification

relevant qualifications

educational requirements

Associate Degree/Diploma