Regulatory & Quality Lead – AI IVD Diagnostics

Job 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 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 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 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.