QA/RA Specialist

Summary

Join Promaton, a remote-first medical device startup, as a Quality Assurance & Regulatory Affairs (QA/RA) professional. You will play a key role in ensuring the quality and regulatory compliance of our innovative AI-driven software. Responsibilities include guiding product development teams, implementing streamlined processes, mitigating compliance risks, and fostering a culture of quality. The ideal candidate possesses extensive experience with ISO 13485, ISO 14971, and IEC 62304, along with a strong understanding of software development processes. Promaton offers excellent employment terms, remote work flexibility, professional development opportunities, and a strong company culture.

Requirements

• 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)

Responsibilities

• 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

Preferred Qualifications

• 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

Benefits

• 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!