Qa & Ra Officer

Nicolab; Melbourne; Vor Ort; AUD 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Flexible Employment Agreement

Flexible working hours

Laptop + home office equipment

Commuting to work costs reimbursement

Pension plan scheme

Employee Stock Option Plan (ESOP)

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Communication

Fluent English

Attention to detail

Proactive problem solving

Project management

Ausbildung

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

Tools

ISO 13485

Jobbeschreibung

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, including notified body and FDA inspections, and follow up on findings with clear corrective and preventive actions (CAPA).
• 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.
• Support post-market surveillance, complaint handling and vigilance reporting.
• Train colleagues, customers and partners on quality and regulatory topics so they get the most out of our clinical solutions while staying compliant.
• Act as a go-to contact for quality and regulatory questions across the company, helping teams build compliance into their daily work from the start.

You'll join a small, ambitious team where your work is visible, your ideas count, and you can grow along with the company.

Your profile

Qualifications

• You are located in Australia, India, The Philippines or in another APAC country.
• A 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 software as a medical device (SaMD) or AI-based products is a big plus.
• Hands‑on experience with ISO 13485 and the EU MDR, and a working knowledge of FDA requirements (QMSR, 510(k)).
• Familiarity with related standards such as IEC 62304, ISO 14971 and IEC 62366.
• Experience writing and maintaining technical documentation and supporting audits by notified bodies or regulators.
• A structured, precise way of working, with a practical, solution-focused mindset. You know how to make compliance work in a fast-moving scale-up.
• Strong communication skills, so you can explain regulatory requirements clearly to engineers, clinicians, customers and partners.
• Fluent English, written and spoken, additional language is a plus.
• Proactive, independent and eager to learn about international market registrations as the company grows.

Why us?

We Offer

• Chance to make a real difference in patients' lives
• Work in a stimulating environment with a motivated team
• Flexible Employment Agreement: Part time / Full time / Freelance
• Flexible working hours
• Flexible paid time off*
• Laptop + home office/IT equipment*
• Commuting to work - costs reimbursement
• Pension plan scheme*
• Employee Stock Option Plan (ESOP)*
• Corporate programs including Employee Referral Program with rewards
• Learning & Development opportunities including in-house training and coaching, professional certifications, and over 22,000 courses on LinkedIn Learning Solutions and much more

*All benefits and perks are subject to certain eligibility requirements

Application Process

• Interview with HR
• Interview Hiring Manager - Prior employment verification check (reference check)
• Meet & Greet CEO

Interviews are in English

About us

At Nicolab, you’ll be joining a passionate and driven team that thrives on pushing boundaries in the medtech industry. Founded in 2015, Nicolab emerged from the transformative MR CLEAN trial that revolutionized acute stroke care. Since then, we’ve been on a mission to empower healthcare professionals with swift, reliable access to life‑saving information. Headquartered in Amsterdam and growing globally, Nicolab is an Australian‑based unlisted public company combining cutting‑edge AI solutions with the mission to improve patient outcomes. Our flagship products, StrokeViewer and Nicolab Assist, have already helped thousands of patients avoid severe, long‑term disabilities. And we’re just getting started.

At Nicolab, every day brings new opportunities and challenges, whether it’s innovating for better care, collaborating with world‑renowned institutions, or driving transformative change in healthcare. It’s a dynamic, fast‑paced environment where your expertise can make a meaningful difference.

We’re first tackling the major issue of stroke, the leading cause of life‑long disability, where we will ensure every patient gets the right treatment in time. Watch more here.

At Nicolab, you’ll join a young and ambitious company where clinical insight directly shapes products and where decisions move fast. We work at a high, agile pace, giving you significant responsibility, real ownership, and a direct role in shaping the future direction of the company as we continue to scale. You will operate in a unique environment that brings together academic excellence and industry collaboration. You’ll work closely with university hospitals and research institutions to build strong clinical evidence, while also collaborating with established partners such as Philips on international initiatives. This combination allows you to influence both rigorous clinical research and large‑scale healthcare innovation.

You will work in an international, mission‑driven team with close connections to leading clinical and academic institutions. You’ll be exposed to all aspects of a growing scale‑up and have the opportunity to expand your scope and impact over time as Nicolab evolves.

Most importantly, you’ll be part of a mission‑driven team focused on improving acute care. Nicolab offers flexible working arrangements and competitive compensation.

and start your journey with Nicolab!