Regulatory Affairs and Quality Associate
An exciting opportunity is available for a skilled Regulatory Affairs and Quality Associate to join a dynamic team in Australia. This role involves supporting regulatory and quality compliance for a diverse portfolio of products within the medical devices and in vitro diagnostics (IVD) sectors.
Key Responsibilities:
Prepare and submit applications for product registration and modifications in alignment with business strategies.
Stay informed on regulatory changes, assess their impact, and support audits and recalls.
Collaborate with internal stakeholders and external regulatory bodies to ensure compliance.
Maintain up-to-date knowledge of ISO , ISO standards, the Therapeutic Goods Act , and relevant Federal and State regulations.
Contribute to the development, implementation, and optimization of quality management systems and processes.
Engage in product vigilance activities, including reporting incidents to the Therapeutic Goods Administration (TGA).
Support and participate in
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