QA/RA Specialist | IVD Start-up | BarcelonaAn innovative IVD start-up is seeking a Junior QA/RA Specialist to help build and implement their Quality & Regulatory function as they prepare for CE marking of a Class C diagnostic device for kidney disease detection.Key Focus Areas: Support implementation and maintenance of ISO compliant QMS including SOPs, work instructions, and quality documentation Assist in preparation and submission of the Regulatory Dossier for CE Marking (Class C IVD) Coordinate with Notified Body and participate in regulatory interactions Manage technical documentation including performance evaluation planning, risk management files, and design control evidence Ensure compliance with EU IVDR and track regulatory timelines and deliverables Collaborate with R&D, clinical partners, and external manufacturers to support industrialization Requirements: 3-5 years experience in QA/RA within IVD, medical devices, biotech, or diagnostics Knowledge of EU IVDR, ISO, design controls, and technical documentation Experience supporting Notified Body interactions Strong attention to detail with ability to work cross-functionally in a fast-paced environment Good communication and project management skills Benefits: Ground-floor opportunity to build a regulatory & quality function from scratch Direct mentorship and exposure to senior leadership (CEO/CTO) Hands-on involvement in CE marking process and industrialization Long-term career progression as the company scalesIf you're interested in learning more, feel free to reach out or apply below:? ? QualityAssurance RegulatoryAffairs IVD MedicalDevices Barcelona Hiring