Regulatory & Quality Lead – AI IVD Diagnostics
hace 5 horas
We are facing a real challenge and looking for the right person to join our adventure.SpotLab is a frontier AI laboratory dedicated to advancing biopharmaceutical research and diagnostic innovation through reliable and cutting‑edge AI solutions. As a growing startup developing AI products for medical diagnosis, we need someone who can help us streamline processes and navigate regulatory changes to ensure compliance.SpotLab has built a solid foundation in quality and regulatory affairs, including: the In Vitro Medical Device Manufacturer License granted by the Spanish Medicines Agency, a Quality Management System following ISO 13485 standards, CE Marking for two AI diagnostic products under the IVDD, and ISO 27001 certification. Now, we need to continue evolving our approach for the dynamic regulatory landscape.This role offers a meaningful mission: you will help certify AI models for microscopy images in hematology and infectious diseases —pioneering a new era with real impact on patients' lives worldwide.We have received more than 10 international awards, including the Seal of Excellence of the European Union. We are a multidisciplinary team with gender parity where engineers, doctors, clinical researchers, business managers, and others with diverse professional backgrounds complement each other.Key ResponsibilitiesLead theCE marking plan and executionto certifyAI-based IVD diagnostic products .OwnIVDR regulatory strategyand align product roadmap, evidence, and documentation to regulatory timelines.Evolve and maintain ascalable QMS(ISO 13485-aligned).Drivetechnical documentationand conformity assessment readiness.Implementrisk managementandPMS/vigilanceprocesses.Coordinate withnotified bodies and authorities .Work with AI/engineering to ensure compliance withEU AI Act obligations .Support regulatoryaudits , internal audits, and supplier evaluation meetingsExperience inSaMD (Software as a Medical Device)regulatory frameworks and compliance activities.Experience withEU medical device regulations , includingIVDR (EU) 2017/746and/or MDR (EU) 2017/745.Understanding ofemerging AI regulations in healthcare , including theEU AI Act , and the ability to translate them into practical compliance actions.Proven ability tointerpret and apply regulatory requirementsspecifically forAI-based systemsin the medical sector.Excellentanalytical skills , with strongattention to detailand clear, structuredcommunication(written and verbal).Advanced English and Spanishproficiency (verbal and written).Ability to thrive in afast-changing environmentand collaborate effectively withmultidisciplinary teams .University degreeinEngineering ,Medicine ,Pharmacy ,Law , or another relevant scientific discipline.#J-18808-Ljbffr
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Regulatory & Quality Lead – AI IVD Diagnostics
hace 6 días
Madrid, España SpotLab A tiempo completoWe are facing a real challenge and looking for the right person to join our adventure. SpotLab is a frontier AI laboratory dedicated to advancing biopharmaceutical research and diagnostic innovation through reliable and cutting‑edge AI solutions. As a growing startup developing AI products for medical diagnosis, we need someone who can help us streamline...
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Regulatory & Quality Lead – AI IVD Diagnostics
hace 3 minutos
Madrid, Madrid, España Spotlab A tiempo completoJob DescriptionWe are facing a real challenge and looking for the right person to join our adventure.SpotLab is a frontier AI laboratory dedicated to advancing biopharmaceutical research and diagnostic innovation through reliable and cutting-edge AI solutions. As a growing startup developing AI products for medical diagnosis, we need someone who can help us...
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Regulatory & Quality Lead – AI IVD Diagnostics
hace 6 días
MADRID, Maryland, Spain SpotLab A tiempo completoJob description We are facing a real challenge and looking for the right person to join our adventure.SpotLab is a frontier AI laboratory dedicated to advancing biopharmaceutical research and diagnostic innovation through reliable and cutting-edge AI solutions. As a growing startup developing AI products for medical diagnosis, we need someone who can help...
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Madrid, España SpotLab A tiempo completoWe are facing a real challenge and looking for the right person to join our adventure. SpotLab is a frontier AI laboratory dedicated to advancing biopharmaceutical research and diagnostic innovation through reliable and cutting‑edge AI solutions. As a growing startup developing AI products for medical diagnosis, we need someone who can help us streamline...
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Regulatory & Quality Lead — AI IVD Diagnostics
hace 5 horas
Madrid, España SpotLab A tiempo completoA pioneering AI laboratory in Madrid is seeking a dedicated Regulatory Affairs Specialist to lead compliance for AI-based diagnostic products. This role includes developing CE marking plans, managing regulatory strategies, and ensuring adherence to evolving healthcare standards. Ideal candidates will have a strong background in medical device regulations,...
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Regulatory & Quality Lead — AI IVD Diagnostics
hace 4 días
Madrid, España SpotLab A tiempo completoA pioneering AI laboratory in Madrid is seeking a dedicated Regulatory Affairs Specialist to lead compliance for AI-based diagnostic products. This role includes developing CE marking plans, managing regulatory strategies, and ensuring adherence to evolving healthcare standards. Ideal candidates will have a strong background in medical device regulations,...
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Regulatory & Quality Lead, AI Diagnostics (IVD)
hace 4 días
madrid, España Spotlab A tiempo completoAn innovative AI laboratory in Madrid is seeking a Regulatory Compliance Lead to oversee the CE marking and certification of AI-based diagnostic products. This role requires in-depth knowledge of EU medical regulations and the ability to implement compliance strategies for cutting-edge AI solutions. Ideal candidates will possess a relevant university degree...
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IVD Diagnostics Territory Sales Leader
hace 7 días
madrid, España Shenzhen New Industries Biomedical Engineering A tiempo completoA leading biomedical engineering firm is seeking a Sales Manager to drive sales growth for their diagnostics portfolio in Madrid, Spain. The ideal candidate will develop key relationships, identify new business opportunities, and collaborate with internal teams. Requires at least 5 years of experience in the IVD industry, especially in immuno and biochemical...
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Senior Director, Digital Diagnostics
hace 5 horas
Madrid, España Werfenlife SA. A tiempo completoA global diagnostics leader is seeking a Senior Director, Digital Products & Innovation in Barcelona to drive strategy for customer-facing digital solutions. This role involves leading partnerships, ensuring compliance with IVD standards, and managing a team to enhance lab efficiency and customer outcomes. Candidates should have a solid background in digital...
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Madrid, España Financecolombia A tiempo completoWe are facing a real challenge and looking for the right person to join our adventure.SpotLab is a frontier AI laboratory dedicated to advancing biopharmaceutical research and diagnostic innovation through reliable and cutting-edge AI solutions. As a growing startup developing AI products for medical diagnosis, we need someone who can help us streamline...
