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APS 6 Project and Research Officer/APS 5 Project Officer

Section Responsibilities
  
Our client assesses clinical information submitted by medical device manufacturers/sponsors. They prepare assessment reports on medical devices and submissions to expert committees. They also assess special access scheme and authorised prescriber applications. They provide clinical advice/liaison with health stakeholders. They apply a risk-based approach to the assessment and approval of medical devices for supply in Australia to ensure these devices meet Australian regulatory requirements.  

Start Date
1 July
  
Location
ACT
  
Length of Contract
12 months

  
Position Details – APS 6 Project and Research Officer

Areas of Responsibility
  
The APS 6 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.
  
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

Capabilities, Skills, and Qualifications
  
Skills Required  

  • 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
  • Strong written and verbal communication skills
  • Technical expertise and experience relevant to the use, assessment, manufacture, design, testing, and monitoring of medical devices

Mandatory Qualifications:  

  • Relevant qualifications in science related field of study or biomedical engineering

Position details – APS 5 Project Officer
  
The Services which the Contractor must provide and perform consist of the following:  

  • Providing support and assistance in coordination of program and project level activities including preparing drafting project artefacts.
  • Assistance with providing secretariat services for various Committees and forums and the ability to coordinate and book meeting to support weekly and fortnightly reporting and coordination activities.
  • Ability to assist and provide input to project and reporting documents, 
  • Experience in maintaining a robust reporting framework, including project updates, timelines, and IT activities.
  • Experience with drafting briefs, power point presentations and reports
  • Experience in organising meetings, conference, and workshops
  • Providing quality control over coordination, governance, reporting frameworks, and the written work produced for the Medical Devices Program reform work.
  • Ability and experience working with stakeholders to assist with project management, including planning, objective setting, timeline management, and risk identification and mitigation.
  • Continuously improving the quality of all the above and utilising various reports to complete other work and reporting
  • Demonstrated ability in managing multiple tasks and requests with limited lead times.
  • Demonstrated ability to work in a team and contributed to the team and program objective in a professional manner

Capabilities, Skills, and Qualifications
  
Key Capabilities
  
The ideal candidate will be able to demonstrate the following capabilities:  

  • Project or program management capabilities, including ability to manage competing deadlines, maintaining clear pipelines of work and weekly updates, adjusting as needed, and identifying and managing risks to completion of work.
  • Work with staff inside and outside the section to continuously improve the quality of processes and products.
  • Good communication and interpersonal skills, including the ability to communicate the relationship between operational activities and organisational goals, and using different types of verbal and written communication styles to explain information in plain English for various audiences.
  • Assist with managing robust reporting framework to a high quality, including activity, project, legislative, and program levels of reporting.

Skills Required  

  • Administration and coordination, Secretariat, Project planning and management, Analysis and critical thinking, Draft material for appropriate audience (and Government)
  • Ability to work independently with limited guidance and undertake research
  • Able to build and maintain relationships across a range of stakeholders

Qualifications
  
A background or experience in the public service, and preferably exposure to providing administrative support to either programs or project level activities 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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