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 requirementsApplication Process
- Interview with HR
- Interview Hiring Manager
- Prior employment verification check (reference check) - Meet & Greet CEO
Interviews are in English