Enovis is seeking a Senior Regulatory Affairs Specialist in Brisbane to lead regulatory strategies for enabling technologies in orthopedics, including SaMD products and machine learning features.
You will develop submissions and liaise with FDA, EU Notified Bodies, and Australian regulators to support market clearance.
You will collaborate with clinical, quality and product teams to ensure regulatory compliance across US, EU and AU, drive post-market surveillance and maintain registrations and
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📌 Senior Regulatory Affairs Lead – Medical Devices & Samd (Brisbane)
🏢 Enovis Surgical Australia
📍 Brisbane
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