QA & RA Officer

About the role

Nicolab is a fast-growing medical device company whose AI-powered stroke imaging software is used by more hospitals, and which is expanding its product range and international markets. As QA & RA Officer you will help keep the company's quality management system compliant with international standards and regulations, including ISO 13485, the EU MDR and FDA QMSR, and help maintain and obtain registrations in target markets. The role suits someone based in Australia, India, the Philippines or another APAC country.

Key responsibilities

• Write and maintain technical files for products, working with R&D, Product and Clinical teams
• Keep the QMS up to date: draft and review procedures, manage document control and ensure processes match practice
• Prepare and run internal and external audits, including notified body and FDA inspections, and follow up findings with CAPA
• Support product registrations and renewals, handling submissions and questions from authorities and distributors
• Monitor regulatory changes and turn them into practical actions
• Support post-market surveillance, complaint handling and vigilance reporting
• Train colleagues, customers and partners on quality and regulatory topics
• Act as a go-to contact for quality and regulatory questions across the company

Required profile

• Bachelor's or Master's degree in a relevant field such as biomedical engineering, life sciences, health sciences or technical medicine
• At least 2 years of experience in quality assurance and/or regulatory affairs in the medical device industry
• Experience with SaMD or AI-based products is a big plus
• Hands-on experience with ISO 13485 and the EU MDR, and working knowledge of FDA requirements (QMSR, 510(k))
• Familiarity with IEC 62304, ISO 14971 and IEC 62366
• Experience writing technical documentation and supporting audits by notified bodies or regulators
• Fluent written and spoken English; additional language is a plus

What we offer

• Part-time, full-time or freelance flexible employment agreement
• Flexible working hours and flexible paid time off
• Laptop and home office/IT equipment, commuting costs reimbursed
• Pension plan scheme and employee stock option plan
• Employee referral program with rewards
• Learning and development, including in-house training, coaching and professional certifications

The application process includes an interview with HR, an interview with the hiring manager, reference checks and a meet-and-greet with the CEO; interviews are in English.