Quality and Regulatory Manager for Health AI Products
hace 2 días
Quality and Regulatory Manager for Health AI Products Spotlab Madrid, Community of Madrid, Spain Join or sign in to find your next job Join to apply for the Quality and Regulatory Manager for Health AI Products role at Spotlab Quality and Regulatory Manager for Health AI Products Spotlab Madrid, Community of Madrid, Spain Join to apply for the Quality and Regulatory Manager for Health AI Products role at Spotlab 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. We are a multidisciplinary team with gender parity where engineers, doctors, clinical researchers, business managers, and others with diverse professional backgrounds complement each other. Contribute to the company's regulatory strategy for AI products in the medical sector Support the CE Marking process for In Vitro Medical Devices, including artificial intelligence algorithms for medical diagnosis Oversee necessary corrective and preventive actions according to quality management procedures Act as the contact point for regulatory authorities on compliance matters Review and evaluate product-related incidents and establish communication channels with authorities Collaborate on health authorization applications and clinical studies supervision Maintain regulatory competence and ensure staff training on requirements University degree in Engineering, Medicine, Pharmacy, Law, or relevant scientific discipline Minimum 2 years in regulatory affairs and quality management for medical devices Experience in SaMD (Software as a Medical Device) regulation Advanced English and Spanish (verbal and written) Knowledge of emerging AI regulations in healthcare, especially the EU AI Act Seniority level Entry level Employment type Full-time Job function Quality Assurance Get notified about new Quality Regulatory Manager jobs in Madrid, Community of Madrid, Spain . Quality Assurance Regulatory Affairs Manager Madrid, Community of Madrid, Spain 5 days ago Field Technical Engineer Intern - Tenerife Madrid, Community of Madrid, Spain 1 day ago
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Quality and Regulatory Manager for Health AI Products
hace 2 semanas
madrid, España Spotlab A tiempo completoQuality and Regulatory Manager for Health AI Products Spotlab Madrid, Community of Madrid, Spain Join or sign in to find your next job Join to apply for the Quality and Regulatory Manager for Health AI Products role at Spotlab Quality and Regulatory Manager for Health AI Products Spotlab Madrid, Community of Madrid, Spain Join to apply for the Quality and...
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Madrid, España Spotlab A tiempo completoQuality and Regulatory Manager for Health AI Products Spotlab Madrid, Community of Madrid, Spain Join or sign in to find your next job Join to apply for the Quality and Regulatory Manager for Health AI Products role at Spotlab Quality and Regulatory Manager for Health AI Products Spotlab Madrid, Community of Madrid, Spain Join to apply for the Quality and...
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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.Todos los candidatos deben asegurarse de leer atentamente la siguiente descripción del puesto y la información antes de enviar su solicitud.SpotLab is a frontier AI laboratory dedicated to advancing biopharmaceutical research and diagnostic innovation through reliable and...
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Quality and Regulatory Manager for Health AI Products
hace 2 semanas
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...
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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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Regulatory Associate
hace 1 semana
Madrid, España Clarity AI A tiempo completoClarity AI is a global tech company founded in 2017 committed to **bringing social impact to markets.** We leverage AI and machine learning technologies to provide investors, governments, companies, and consumers with the right data, methodologies, and tools to make more informed decisions. We are now a team of more than 300 highly passionate individuals...
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Quality and Regulatory Director
hace 4 semanas
Madrid, España ARTO A tiempo completoPosition OverviewThe Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization’s overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP and...
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Quality and regulatory director
hace 3 semanas
Madrid, España ARTO A tiempo completoPosition Overview The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization's overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable Gx P and...
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Quality and Regulatory Director
hace 2 días
madrid, España ARTO A tiempo completoPosition Overview The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization’s overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP and...
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Quality and Regulatory Director
hace 2 días
Madrid, España ARTO A tiempo completoPosition OverviewThe Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization’s overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP and...
