Qa/ra specialist
hace 1 semana
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 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 industrializationRequirements: 3-5 years experience in QA/RA within IVD, medical devices, biotech, or diagnostics Knowledge of EU IVDR, ISO 13485, 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 skillsBenefits: 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 scales If you're interested in learning more, feel free to reach out or apply below:✉ lcattcamfield@barringtonjames.com ☎ +44 (0) 1293 776644#Quality Assurance #Regulatory Affairs #IVD #Medical Devices #Barcelona #Hiring
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QA/RA Specialist
hace 2 semanas
Madrid, España Barrington James A tiempo completoQA/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,...
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QA/RA Specialist
hace 4 semanas
Madrid, España Barrington James A tiempo completoQA/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,...
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QA / RA Specialist
hace 24 horas
Madrid, España Barrington James A tiempo completoQA / RA Specialist | IVD Start-up | Barcelona An 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...
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QA & RA Specialist, IVD Start-up — Barcelona
hace 4 días
madrid, España Barrington James A tiempo completoAn innovative IVD start-up in Madrid is looking for a Junior QA / RA Specialist to establish their Quality & Regulatory function. The role involves supporting ISO 13485 compliance, preparing regulatory submissions, and engaging with Notified Bodies. Ideal candidates should have 3-5 years of experience in QA / RA, knowledge of EU IVDR and ISO 13485, and...
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SaMD QA/RA Associate — Compliance
hace 3 días
Madrid, España Mediktor A tiempo completoA leading healthcare technology firm in Madrid is seeking a QA / RA specialist passionate about technology regulations. In this role, you will ensure compliance with AI and healthcare standards, manage documentation, and participate in audits. Ideal candidates will have a Life Science degree and at least a year of experience in a QA / RA role. The company...
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Teams Specialist
hace 2 semanas
Madrid, España Barrington James A tiempo completoQA/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,...
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QA Specialist
hace 5 días
Madrid, España Project Delivery Partners A tiempo completoPharmEng / Efor is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality, safety, and excellence in everything we do. As we continue to grow, we are looking for a highly qualified and motivated Automation Engineer...
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QA Specialist
hace 3 días
Madrid, Madrid, España Project Delivery Partners A tiempo completoJob Description: PharmEng / Efor is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality, safety, and excellence in everything we do. As we continue to grow, we are looking for a highly qualified and motivated...
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Senior QA Specialist ServiceNow
hace 2 semanas
Madrid, España UST España & Latam A tiempo completoSenior QA Specialist Service Now (Hybrid - Madrid)
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QA Specialist
hace 24 horas
Madrid, España Project Delivery Partners Pte Ltd A tiempo completoPharmEng / Efor is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality, safety, and excellence in everything we do. As we continue to grow, we are looking for a highly qualified and motivated Automation Engineer...
