Evolve Scientific in Sydney seeks a Senior Quality & Regulatory Affairs Specialist to lead regulatory submissions across Australia, Europe, Japan and the USA, and maintain ISO 13485 QMS compliance. You’ll work with engineering and product teams to navigate EU MDR, TGA, FDA/PMDA requirements and drive CAPA and post-market surveillance.
Ideal candidates bring hands-on, independent problem-solving in a small, collaborative MedTech environment, with solid audits experience and readiness to support
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📌 Global MedTech QA/RA Specialist (Hybrid) (Sydney)
🏢 Evolve Scientific
📍 Sydney
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