Enovis Australia seeks a Senior Regulatory Affairs Specialist to lead regulatory strategies for medical devices, including SaMD, across US, EU, and AU markets with cross‐functional teams.
You will develop submissions, liaise with authorities, and drive compliance with TGA regulations, EU MDR, ISO ***** and ISO ***** while supporting AI/ML-enabled enabling technologies within the portfolio.
This role requires hands‐on experience with 510(k) submissions, Notified Bodies, and post‐market
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📌 Senior Regulatory Affairs Lead For Medical Devices Samd (Queensland)
🏢 Enovis
📍 Queensland
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