Benefits

Gain unique experience in technical and regulatory affairs working for the Medical Devices Authorisation Branch of the TGA.

About the company

The Medical Devices Authorisation Branch of the TGA evaluates medical devices, including in vitro diagnostic medical devices (IVDs), and monitors them throughout their lifecycle to ensure they continue to meet an appropriate level of quality, safety, and performance.

About the opportunity

A 12-Month contract has become available at the Devices Conformity Assessment Section (DCAS) within the Medical Devices Authorisation Branch (MDAB). DCAS is responsible for the pre-market conformity assessment certification of manufacturers of medical devices and IVDs. As the compliance Assessor you will be utilising complex regulatory processes and technical assessments of applications for medical devices. You will evaluate technical documentation and data and account findings clearly and articulately through technical reports. You will also be liaising with internal and external stakeholders in various business improvement or reform project activities.

Duties

• Support the team to process and evaluate high risk medical devices conformity assessment applications and the management of work queues within tight timeframes
• Research, interpret and apply legislation, regulatory guidelines, international standards and best-practice when undertaking medical device evaluations
• Preparing reports that are well-reasoned, clear, concise and critically reviewed for decision in a timely manner
• Support reporting and analytics of regulatory processes to inform section management and the executive
• Contribute expertise to branch communications and stakeholder engagement activities
• 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 broader organisational objectives by undertaking other tasks as required.

Skills and Experience

• Relevant Qualifications in biomedical engineering or related field
• Experience in regulatory and technical assessments in medical devices or IVD's
• Ability to interpret, draft and review policy and procedural documentation.
• Ability to maintain the knowledge of applicable legislative and reporting requirements, Australian and International standards, best practice models and quality assurance procedures
• Ability to communicate complex regulatory and/or technical matters clearly and concisely to a range of internal and external stakeholders

How to Apply

Click apply or contact Madeleine Byrnes, Sourcing Consultant on 0288778703 for a confidential discussion.