QC/RA Manager (m/w/d)

We are pioneering organoid research at the intersection of 3D cell culture technology and data-driven science. As we bring OrganCore™ –  our integrated lab instrumentation platform – to research and pharmaceutical markets, building a robust quality foundation is essential to our growth. We’re looking for a Quality & Regulatory Affairs Manager to establish and maintain our quality management system, develop our regulatory strategy for lab-use instrumentation, and ensure compliance as we scale from early-stage development to commercial launch.

• Build and maintain the Quality Management System (QMS)
• Develop and implement regulatory strategy for product development
• Create and manage quality documentation, SOPs, and work instructions
• Conduct risk management activities (ISO 14971)
• Prepare and support regulatory submissions and audits
• Manage supplier qualification and monitoring
• Drive CAPA processes and continuous improvement initiatives
• Liaise with notified bodies and regulatory authorities
• Support product classification and intended use definition
• Train internal teams on quality and regulatory requirements
• Maintain post-market surveillance documentation

• 5+ years experience in QC/RA in medical devices, IVD, or biotech
• Strong knowledge of ISO 13485, ISO 14971, and relevant lab equipment standards
• Experience building or maintaining a QMS from early stage
• Familiarity with GMP principles
• Experience with notified body or regulatory authority interactions is a plus
• Proven ability to build regulatory frameworks from scratch in an early-stage environment
• Hands-on mentality and ability to work independently
• Fluent English at C1/C2 level (written and spoken)
• BSc/MSc in Life Sciences, Engineering, or related field

• Competitive salary starting from €60.000 gross per year (full-time), with potential increase based on experience
• Performance bonuses
• Equity program
• Permanent, full-time contract
• Flexible working arrangements (hybrid model)
• Professional development and training opportunities
• Direct access to senior leadership and real ownership over your domain from day one
• Clear growth path toward a senior leadership role
• Dynamic, collaborative team environment
• Opportunity to shape cutting-edge biotech innovation