Medical Device Quality Assurance jobs

• APS Level 6
• $101,679 - $114,709
• Canberra, ACT, Brisbane, QLD, Melbourne, VIC, Sydney, NSW

APS6 regulatory officers contribute to the delivery of regulatory, operational and reform activities within the Medical Devices Authorisation Branch. Regulatory officers are expected to exercise initiative, sound judgement and accountability in delivering outcomes and may be assigned duties based on business and operational requirements.
Successful candidates will be placed in a merit pool and may be considered for roles across a range of functions within the Medical Devices Authorisations Branch, including regulatory assessment of medical devices (including IVD’s), regulatory operations, policy and reform, stakeholder engagement, data and business improvement activities.

Key responsiblities:

• Assess and manage complex medical device and IVD applications, regulatory matters and casework.
• Interpret and apply legislation, policies and regulatory frameworks to support sound decision-making.
• Prepare high-quality decisions, briefs, correspondence and regulatory advice.
• Deliver regulatory, operational, policy and reform activities in line with organisational priorities.
• Analyse information and data to identify risks, issues and opportunities for continuous improvement.
• Build and maintain effective relationships with internal and external stakeholders to support regulatory outcomes.
• Manage competing priorities, projects and work programs while ensuring compliance with governance requirements.
• Contribute to a positive team culture by supporting colleagues and upholding APS Values, Employment Principles and the APS Code of Conduct.