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.

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!

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.