Lead Group in Brisbane is seeking a Senior Regulatory Affairs Specialist for medical devices, software and AI-enabled tech. You will develop regulatory strategies, lead global submissions, and liaise with FDA, EU Notified Bodies and TGA to ensure compliance across US, Europe, and Australia.
The role requires 5+ years in medical devices, solid knowledge of FDA and EU MDR, ISO standards, and cross-functional collaboration across engineering and quality teams.
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📌 Senior Regulatory Affairs Lead Med Devices & Ai Brisbane Brisbane City (Australia)
🏢 Lead Group
📍 Australia
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