SDI Limited, a Melbourne-based medical devices company, seeks a Technical Documentation Specialist to manage EU MDR/ISO 13485 compliant tech docs for recent and legacy devices. The role covers evidence mapping, risk controls and lifecycle documentation, with collaboration across R&D;, QA, Regulatory and Marketing.
You will ensure traceability, update templates, and support regulatory submissions and audits in a high‑compliance workplace. Bayswater/Montrose location; 38 hours per week.
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📌 Medical Devices Regulatory Documentation Specialist Melbourne
🏢 SDI
📍 Melbourne