QA & RA Officer

About the role

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. 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.

What you'll do

• 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, including notified body and FDA inspections
• Support product registrations and renewals in new and existing markets, handling submissions and questions from authorities and distributors
• Monitor regulatory changes and translate them into practical actions for the organization

What you need

• 2–5 yrs of experience
• Regulatory affairs
• ISO 9001
• Complaint handling
• Any graduate