N
Posted 1h ago•Australia
QA & RA Officer
MiddleAustraliaSalary undisclosed
Job Description
Your mission
Job Description
Nicolab is growing fast. More hospitals are using our AI-powered stroke imaging software, and we keep adding products and entering new international markets. Every new product, market and software release raises the bar for compliance. We're strengthening our Quality & Regulatory team so we can keep that pace without cutting corners. As our QA & RA Officer, you'll help make sure Nicolab's quality management system stays compliant with international standards and regulations, including ISO 13485, the EU MDR and FDA QMSR. You'll also help us keep our current registrations and get new ones in our target markets. Your work directly affects how quickly our technology reaches stroke patients and how much clinicians can trust it.
Key Responsibilities
- Write and maintain technical files for our products as regulations require, working closely with R&D, Product and Clinical teams.
- Keep our QMS up to date: draft and review procedures, manage document control, and make sure processes reflect how we actually work.
- Help prepare and run internal and external audits
Ready to apply? Optimize your CV for this specific jobAI customizes your experience bullets and increases chances to get hired.
