About us

OurMind is active in building an AI platform that alleviates the administrative burden on healthcare professionals, allowing them to focus more on patient care. The company’s innovative solutions, such as the Ambient AI and OurMind Assistant, are designed to enhance healthcare capacity and efficiency, currently being utilized by 14 Dutch hospitals.

Job description

As a QA/RA Lead, you will be responsible for establishing and maintaining the quality management system (QMS) and ensuring compliance with regulatory standards. You will work closely with engineering, product, and clinical teams to certify our AI platform under the MDR (Class IIb). Your role is crucial in building trust with healthcare professionals and supporting the company's growth by managing quality and regulatory affairs effectively.

• Set up our quality management system (QMS, ISO 13485) and prepare for the first audit
• Work closely with our regulatory consultant and gradually take over responsibilities
• Build and own the technical documentation for our MDR Class IIb certification, targeting submission for Q2 2027
• Familiarize yourself with the product, engineering team, and hospital partners to document accurately
• Maintain the QMS and integrate it into daily team operations
• Evaluate new features for regulatory impact and necessary documentation
• Monitor applicable regulations like MDR and the EU AI Act, translating them into actionable steps
• Manage risk, post-market surveillance, and change management

Relevant work experience

• At least 5 years of experience in regulatory affairs or quality management
• Hands-on experience with software as a medical device (SaMD) and the MDR
• Familiarity with ISO 14971 and IEC 62304

Benefits

• Professional development budget
• €500 per year for home office setup
• Flexible working hours
• Key role in a growing healthcare AI scale-up

Skills required for the job