QA & Regulatory Affairs Lead - MedTech AI

Nicolab; Melbourne; On-site; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Flexible Employment Agreement

Flexible working hours

Laptop + home office equipment

Commuting to work costs reimbursement

Pension plan scheme

Employee Stock Option Plan (ESOP)

Job summary

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.

Qualifications

• Bachelor's or Master's degree in a relevant field.
• At least 2 years in quality assurance and/or regulatory affairs in medical devices.
• Experience with SaMD or AI-based products is a plus.
• Hands-on with ISO 13485, EU MDR, and FDA QMSR.

Responsibilities

• Write and maintain technical files for products per regulations, collaborating with R&D, Product and Clinical teams.
• Keep the QMS up to date: draft/review procedures, manage document control, reflect actual workflows.
• Assist internal and external audits, including notified body and FDA inspections, with CAPA follow-up.
• Support product registrations and renewals in new/existing markets, handling submissions and inquiries.
• Monitor regulatory changes and translate them into concrete actions for the organization.
• Support post-market surveillance, complaint handling and vigilance reporting.
• Train colleagues, customers and partners on quality and regulatory topics to ensure compliant use of our clinical solutions.
• Act as a go-to contact for quality/regulatory questions across the company, embedding compliance from the start.

Skills

Communication

Fluent English

Attention to detail

Proactive problem solving

Project management

Education

Bachelor's or Master's in biomedical engineering, life sciences, health sciences, or related field

Tools

ISO 13485

Job description

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.