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88,000+ live jobsHybrid in Madrid·Full-time·Added over a year ago
This job was published a year ago
Full-time hours
Per the ad.
Hybrid
Office and home days — the ad has the split.
Have the right to work in Spain
SpotLab doesn't mention sponsorship in the ad.
Speak fluent Spanish
Listed as a requirement in the ad.
Work in English
English is required, per the ad.
Be near Madrid, Spain (Hybrid) for hybrid days
No relocation package mentioned.
University degree
“University degree in Engineering, Medicine, Pharmacy, Biotechnology, Law , or another relevant scientific discipline.” — per the ad.
Experience in SaMD (Software as a Medical Device) regulatory frameworks and compliance activities.
Experience with EU medical device regulations, including IVDR (EU) 2017/746 and/or MDR (EU) 2017/745.
Understanding of emerging AI regulations in healthcare, including the EU AI Act, and the ability to translate them into practical compliance actions.
Proven ability to interpret and apply regulatory requirements specifically for AI-based systems in the medical sector.
Excellent analytical skills, with strong attention to detail and clear, structured communication (written and verbal).
Advanced English and Spanish proficiency (verbal and written).
Ability to thrive in a fast-changing environment and collaborate effectively with multidisciplinary teams.
University degree in Engineering, Medicine, Pharmacy, Biotechnology, Law, or another relevant scientific discipline.
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.
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.
Key Responsabilities:
Lead the CE marking plan and execution to certify AI-based IVD diagnostic products.
Act as the company's PRRC (Person Responsible for Regulatory Compliance) for IVD products.
Own IVDR regulatory strategy and align product roadmap, evidence, and documentation to regulatory timelines.
Evolve and maintain a scalable QMS (ISO 13485-aligned).
Drive technical documentation and conformity assessment readiness.
Implement risk management and PMS/vigilance processes.
Coordinate with notified bodies and authorities.
Work with AI/engineering to ensure compliance with EU AI Act obligations.
Support regulatory audits, internal audits, and supplier evaluation meetings
SpotLab is a Madrid-based HealthTech company specializing in AI-powered diagnostic solutions for hematology and digital pathology. The company develops advanced algorithms and software to assist medical professionals in analyzing blood samples and pathological images, aiming to improve diagnostic accuracy and efficiency. SpotLab operates at the intersection of artificial intelligence, biomedical engineering, and clinical diagnostics, serving the healthcare industry with innovative tools for laboratories and hospitals.
With its headquarters in Madrid, Spain, SpotLab is deeply embedded in the local innovation ecosystem, collaborating with research institutions and clinical partners. The company offers a dynamic, multidisciplinary work environment that values scientific rigor and technological innovation. For international professionals, SpotLab provides opportunities to work on cutting-edge AI applications in healthcare, with roles spanning research, engineering, regulatory affairs, and business development. The company's international outlook and partnerships make it an attractive destination for talent looking to contribute to the future of medical diagnostics.
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.
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.
SpotLab · Madrid
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or browse Madrid·Healthcare·Mid-level·Hybrid·Digital Health & Mental Wellbeing·Community of Madrid·HealthTech
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€62k - €93k
Blue Card threshold🇬🇧
