Senior Regulatory Affairs Lead, MedTech & AI Software (New South Wales)

Senior Regulatory Affairs Lead, MedTech & AI Software (New South Wales)

15 Sep
|
Enovis
|
New South Wales

15 Sep

Enovis

New South Wales

Job Description

Enovis Corporation is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategies for innovative medical devices, software, and AI-enabled technologies. You will manage submissions across the US, Europe, and Australia, collaborating with Engineering, Clinical, Quality, and Product teams to ensure compliant, market-ready solutions.

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Ideal candidates bring 5+ years in medical devices, robust FDA/EU MDR knowledge, and experience with SaMD/AI.

📌 Senior Regulatory Affairs Lead, MedTech & AI Software (New South Wales)
🏢 Enovis
📍 New South Wales

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