Nicolab is growing its Quality & Regulatory team in Melbourne to support rapid product and market expansion. The QA & RA Officer will help ensure Nicolab's quality management system remains compliant with ISO 13485, EU MDR and FDA QMSR, while supporting registrations in target markets and maintaining current registrations.
You will work with R&D, Product and Clinical teams to draft and review technical files, train staff, and lead audits.
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QA & Regulatory Affairs Lead - MedTech AI in Melbourne employer: Nicolab
Nicolab is an exceptional employer, offering a dynamic work culture that prioritises collaboration and innovation in the healthcare technology sector. As a Remote Technical Implementation & Support Engineer, you'll benefit from flexible working arrangements while being part of a supportive team dedicated to professional growth and development. With opportunities to engage with hospital IT teams across the APAC region, you will play a crucial role in enhancing clinical outcomes, making your work both meaningful and rewarding.