Senior Regulatory Affairs Lead - Med Devices & AI (Brisbane) (Brisbane City)

Senior Regulatory Affairs Lead - Med Devices & AI (Brisbane) (Brisbane City)

01 Sep
|
Lead Group
|
Brisbane City

01 Sep

Lead Group

Brisbane City

Lead Group in Brisbane is seeking a Senior Regulatory Affairs Specialist for medical devices, software and AI-enabled tech. You will develop regulatory strategies, lead global submissions, and liaise with FDA, EU Notified Bodies and TGA to ensure compliance across US, Europe, and Australia.

The role requires 5+ years in medical devices, solid knowledge of FDA and EU MDR, ISO standards, and cross-functional collaboration across engineering and quality teams.

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📌 Senior Regulatory Affairs Lead - Med Devices & AI (Brisbane) (Brisbane City)
🏢 Lead Group
📍 Brisbane City

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