Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 13 days ago

QA & RA Officer

NICo-lab B.V.3 open roles

Where
Australia
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowQA & RA OfficerNICo-lab B.V. · Australia

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on NICo-lab B.V.'s own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

12.9% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.2%1 day
  2. 4.7%3 days
  3. 12.9%7 days
  4. 21.0%14 days
  5. 35.6%30 days
  6. 58.5%60 days
This job: posted 13 days ago

The posting

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

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against NICo-lab B.V.'s own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on NICo-lab B.V.'s form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    NICo-lab B.V.'s answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.