Qa/Ra Officer - Medical Software

Promaton is on a mission to provide fast, more accessible and higher quality dental healthcare to patients all across the globe. We are a remote-first startup with a very strong ‘people first’ culture. Six years after being founded, we have more than 50 team members, multiple live products, a fast-growing user base, 8 patents and are ISO 13485 certified. We are passionate about technical innovation in healthcare, we value autonomy and implement best practices from top tech product companies. See our company page to learn more about what we do.

Your role

We are seeking an experienced Quality Assurance & Regulatory Affairs (QA/RA) professional with a strong foundation in medical device regulations, ISO 13485, ISO 14971, and IEC 62304. The ideal candidate will have a deep understanding of software development processes and possess a practical approach to ensure compliance while facilitating efficient product development. Experience with AI/Artificial Intelligence in medical devices is preferred.

What you’ll do

In this role, you will be a key contributor to the success of our innovative software that is part of medical devices. You will work closely with the current QA/RA Manager to provide guidance and support to product development teams (product managers and engineers) on all aspects of quality and regulatory compliance, including the growing number of AI standards and the new European AI Act. This will involve adapting existing processes and potentially implementing new controls.

Success will be measured by your ability to:

• Enable rapid and compliant product launches: navigate regulations and standards to empower product teams to bring AI-driven medical devices to market quickly and in compliance with applicable requirements.

• Implement streamlined processes that meet regulatory requirements and support efficient product development.

• Proactively mitigate compliance risks, driving continuous improvement to enhance efficiency.

• Cultivate a culture of quality and compliance by building strong relationships with cross-functional teams and fostering a collaborative environment.

Perks

Excellent employment terms

Freedom to work from anywhere (and any time you like). We are a remote-first company by design with people from all over Europe.

‍ Dedicated time for hackathons and research to explore new ideas of your own

Training budget for books, online courses, conferences, or anything else you need to grow

Work with cutting-edge technology at the forefront of rapidly evolving medical innovation

Loads of responsibility, autonomy and a chance to make a real impact

Awesome yearly company retreat and quarterly team events

• ️ Competitive annual leave package that varies by location

Top-notch gear

• ️ Promaton is funded for many years to come, meaning you can have the impact you only get at a startup but with the job security of an established company.

For international candidates: Join us from anywhere through Remote.com in your local country, or become part of our Dutch team, where we are a recognized visa sponsor!

• 
  3+ years of experience with ISO 13485.

• Experience in managing typical QMS processes: document and record control, training, supplier management, Computer Software Validation (CSV), issue resolution (NCs and CAPAs), change management.

• 2+ years of experience as QA/RA with software, including experience with ISO 14971 (risk management) and IEC 62304 (software product development).

• Experience with organizing and documenting verification and validation activities.

• Pragmatic approach balancing fast incremental improvements.

• An independent and self-starter work attitude.

• Willingness to learn, especially on AI regulations and standards.

• Excellent written and verbal communication skills in English.

• Based in a time zone between UTC-1 and UTC+3 (-2 to +2 hours Amsterdam time)

• Ability to fly in for company events 4 times a year (1 week per quarter)

Bonus points

• Experience with QA/RA work in AI-enabled software

• Experience with electronic QMS

• Understanding of basic requirements for an information security management system (ISMS), with some knowledge of ISO/IEC 27001 and/or General Data Protection Regulation (GDPR) topics

Sounds like you? Let's talk!

Good to know:

• It goes without saying that we love the power of AI, but we believe the human touch is irreplaceable in recruitment. We are looking forward to your personalized answers to our screening questions, not ChatGPT's insights!

• Wondering if you should apply if your experience doesn't fit all of the job requirements? In general, we are aiming for an 80% match, so please go ahead if you get excited by the role and by the idea of joining our team!

• Read our blog about How to be successful in our selection process for more tips and tricks!