Job Description
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.
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Key Responsibilities
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Regulatory Submissions: Prepare and file applications for test licenses, manufacturing licenses, import permits, and market authorizations.
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Compliance: Maintain quality systems standards, including Device or Site Master Files and risk management protocols.
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Health Authority Liaison: Direct communication and query responses with regulatory bodies and notified auditors.
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Cross Functional Support: Partner with Research and development, Quality Assurance, and Marketing to review product labeling, Instructions, and promotional content.
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Regulatory Intelligence: Track evolving regional and international laws to assess product safety, efficacy, and lifecycle changes
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📌 Manager Regulatory Affairs (New South Wales)
🏢 Recognized
📍 New South Wales