Global Regulatory Strategy Lead - MedTech & SaMD (Queensland)

Global Regulatory Strategy Lead - MedTech & SaMD (Queensland)

06 Aug
|
Enovis
|
Queensland

06 Aug

Enovis

Queensland

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 (Queensland)
🏢 Enovis
📍 Queensland

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