Enovis Brisbane seeks an experienced Senior Regulatory Affairs Specialist to develop regulatory strategies and manage submissions for SaMD and hardware products. You will lead pre-submission interactions with FDA, Notified Bodies, and TGA while coordinating with clinical and development teams to ensure compliant, timely market access.
The role requires 5+ years in medical devices, knowledge of ISO 13485 and MDR/510(k) processes, and capability to handle global regulatory pathways with AI-enabled
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📌 Global Regulatory Strategy Lead - MedTech & SaMD (Brisbane)
🏢 Enovis
📍 Brisbane
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