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hace 1 semana

Plaza Catalunya, España Barrington James A tiempo completo

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 13485-compliant QMS including SOPs, work instructions, and quality documentationAssist in preparation and submission of the Regulatory Dossier for CE Marking (Class C IVD)Coordinate with Notified Body and participate in regulatory interactionsManage technical documentation including performance evaluation planning, risk management files, and design control evidenceEnsure compliance with EU IVDR and track regulatory timelines and deliverablesCollaborate with R&D, clinical partners, and external manufacturers to support industrializationRequirements:3-5 years experience in QA/RA within IVD, medical devices, biotech, or diagnosticsKnowledge of EU IVDR, ISO 13485, design controls, and technical documentationExperience supporting Notified Body interactionsStrong attention to detail with ability to work cross-functionally in a fast-paced environmentGood communication and project management skillsBenefits:Ground-floor xsgfvud opportunity to build a regulatory & quality function from scratchDirect mentorship and exposure to senior leadership (CEO/CTO)Hands-on involvement in CE marking process and industrializationLong-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

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