APS 6 Project Manager

About the company

Medical Devices Surveillance Branch monitors medical devices, including in vitro diagnostic tests (IVDs) and other therapeutic goods (OTGs), throughout their lifecycle to ensure they continue to meet appropriate levels of quality, safety and performance.

About the opportunity

The APS 6 Project Manager role sits within the Devices Post Market Reforms & Reviews Section. Responsible for complex monitoring, analysis, investigation and review activities for post market regulatory programs for medical devices. In addition, the section is responsible for undertaking the post-market reforms program of work to implement recommendations and commitments made in The Action Plan for Medical Devices.

Duties

• Development of a risk based assessment framework in relation to surface texture for breast implant
• Reinvigoration of the Action Plan consumer working group to co-design consumer friendly documents which translate technical regulatory language into plain English to make documents more accessible to non-expert audiences
• Support establishment of a separate Women's Health working group
• Support the post market enhancements projects as required

Qualifications & Skills required

• Bachelor's degree or equivalent experience in science, engineering or relative discipline
• Solid understanding and experience working with medical device regulation in Australia
• Experienced in government processes and policy writing/development
• Project Planning and management
• Analysis and critical thinking
• Writing for the 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

How to Apply

Click apply or contact Joanna Murphy, Senior Recruitment Consultant on +61 2 8877 8718 for a confidential discussion.

( SK927795A )