As a Manager of Regulatory Affairs for Medical Devices. To leads market approval strategies, manages health authority submissions, and ensures full product lifecycle compliance. Key duties involve working with regional.
Key Responsibilities
Regulatory Submissions: Prepare and file applications for test licenses, manufacturing licenses, import permits, and market authorizations.
Compliance: Maintain quality systems standards, including Device or Site Master Files and risk management protocols.
Health Authority Liaison: Direct communication and query responses with regulatory bodies and notified auditors.
Cross Functional Support: Partner with Research and development, Quality Assurance, and Marketing to review product labeling, Instructions, and promotional content.
Regulatory Intelligence: Track evolving regional and international laws to assess product safety, efficacy, and lifecycle changes
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📌 Manager Regulatory Affairs (Brisbane)
🏢 Recognized
📍 Brisbane