Overview of SNAC

The recent interdisciplinary collaboration between the University of Sydney, SNAC and I-MED will deliver a platform for seamless AI integration into clinical radiology workflows; and develop neuroimaging algorithms that will set a benchmark in diagnostic imaging, drive industry automation and productivity and mine hitherto untapped quantitative imaging data to improve health outcomes. The collaboration is centred on industry-led innovation within the government science and research priority of Health and aligns with the Medical Technologies and Pharmaceuticals growth sector. 

SNAC was established at the Brain Mind Centre to take advantage of unique research capacity in the field and provide a state of the art commercial facility for the quantitative analysis of MRI to the pharmaceutical and other industries since 2012. Together with a dedicated MS clinic, MS Clinical Trials Centre, and MRI unit, SNAC is co-located within the Brain and Mind Centre at the University of Sydney. SNAC offers a unique combination of in-house neuroscience, imaging science, clinical trial, neurology and radiology expertise; and specialises in building novel neuroimaging biomarkers and integrating these into Phase 2-4 clinical trials for the pharmaceutical industry. 

Collaborative partners include:

The University of Sydney. The University of Sydney is Australia’s premier University with an outstanding global reputation for academic and research excellence and employs over 7600 permanent staff supporting over 60,000 students. The University of Sydney's Brain and Mind Centre was established in 2015 for the research and treatment of critical health issues of the 21st century – disorders of the brain and mind.

I-MED Radiology Network. I-MED Radiology Network is the largest provider of clinical radiology service in Australia, providing over five million services a year to the Australian community across all states.

Duties and Key Responsibilities 

  • Preparing and maintaining technical files and design dossiers.
  • Compiling, reviewing, and submitting regulatory submissions to various global notified bodies including but not limited to the TGA and the FDA.
  • Participating in cross-functional projects to provide regulatory strategy and oversight for implantable device and technology development projects locally and globally.
  • Driving project improvement across the Regulatory function.
  • Reviewing protocols and reports and other documentation used to support medical device files.  
  • Remaining up to date with changes within the industry and regulatory environments and performing subsequent gap analyses to understand the effect of changes.
  • Providing mentorship and knowledge sharing within the project team.
  • Supporting internal/external audits as required..
  • Skills, Knowledge and Experience 

    Essential 

  • Minimum 2 years of Regulatory Affairs experience working within the Australian Medical Devices industry, medical device/software industry.
  • Able to draft and complete product Technical File for TGA and FDA compliance.
  • A tertiary qualification in medical, Biomedical, or computer science or identical.
  • Proficiency with technical communication and related software.
  • Excellent written and oral communication skills.
  • Experience operating in a 21 CFR.820, ISO 13485 or ISO 9001 QMS.
  • Desirable 

  • Basic knowledge in radiology imaging, machine learning, and image processing techniques.
  • Proficient knowledge of Therapeutic Goods (Medical Devices) Regulations 2002 for Class1, Class 1S/1M/II, etc,.
  • Proficient knowledge of EC Directive 93/42/EEC and EU MDR 2017/745.
  • Proficient knowledge of FDA 21 CFR part 820, 21 CFR Part 892, especially 510(k) submission.
  • SNAC is an equal employment opportunity employer committed to equity, diversity and social inclusion. 

    Please forward your application letter and CV to info@snac.com.au. We will be reviewing applications as we receive them however due to the volume of the applications, please be informed that only shortlisted candidates will be contacted after the closing date.

    This is a 6-month contract full-time position. An immediate start is preferable.