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Project and Research Officer/Project Officer – Multiple roles

Project and Research Officer
 
The Project and Research Officer is responsible for undertaking the assessment of clinical information for applications for the supply of medical devices in Australia through the preliminary review of clinical evidence and regulatory documentation, and supporting the application of process improvements to enable streamlined assessments.
 
Start date
ASAP
  
End date
12 Months from Commencement
  
Possibility of extension
Yes
  
Location
ACT

Key duties

  • Undertaking the assessment of clinical and regulatory information submitted by medical device manufacturers/sponsors, documenting the results in clearly articulated reports and ensuring recommendations are governed by the application of the Australian therapeutic goods regulatory framework
  • Supporting the application of process improvements for the assessment of clinical evidence by assisting medical advisors in the preparation of reports and drafting work instructions. Providing timely, quality and accurate advice on issues relating to medical device regulation and interpretation of legislation and guidelines
  • Contributing to the development and revision of technical and administrative procedures and documentation within the Branch. Managing record keeping in accordance with the regulatory and legislative requirements and whole of government policy and standards 

Required skills

  • An understanding of the Australian regulatory requirements for medical devices, or the ability to quickly develop this understanding
  • Ability to interpret, draft and review policy and procedural documentation
  • Ability to prepare clearly articulated assessment reports in a timely manner and in accordance with guidelines and the medical devices legal framework
  • Ability to apply work knowledge, legislation, policy, procedures and guidelines to situations involving a high level of complexity and sensitivity which require considerable interpretation and analysis

Mandatory Qualifications

  • Bachelor degree in science related field of study or biomedical engineering 

Project Officer
  
The Project Officer will assist with a range of research and analysis activities to support new regulatory proposals, updating regulatory guidelines; preparing materials to operationalise new or update existing policies or schemes; and liaising with both internal and external stakeholders.
   
Duties of Position
  
Specific duties include: 

  • Assist in coordinating, managing, and delivering projects for the Branch. Assist in planning, developing, and managing communication activities including internal and external stakeholder consultation.
  • Conduct research and analysis activities. Assist in the preparation of a variety of written materials, including Ministerial correspondence; committee papers; PowerPoint presentations; policy, guidance, and other technical documents.
  • Review related information on website to ensure it is current and draft material for publication. Resolve moderately complex enquiries from stakeholders and provide information and advice as a representative.  

Mandatory requirements
  
Candidates must be able to demonstrate:

  • Experience in coordinating, managing, and delivering projects.
  • Highly developed strategic, analytical, problem solving and planning skills.
  • Highly developed written skills, including drafting, editing and the ability to understand and distil complex information.
  • High level verbal communication skills with ability to liaise effectively with a diverse range of stakeholders.
  • Ability to prioritise tasks, respond positively and flexibly to change and produce quality outputs to tight deadlines.
  • Highly developed leadership and management skills.  

Desirable  

  • Tertiary training in scientific discipline(s) transferable to medicine regulation.

Qualifications in Project management, Communication, Public Relations, or related discipline would be highly regarded. 

If interested, please apply directly through the links provided. Alternately, contact Kalpana Palaniyappa for more information.
  
Kalpana Palaniyappa
0403 200 666  
kalpana.palaniyappa@calleo.com.au 

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