Regulatory & Quality Lead – Ai Ivd Diagnostics

We are facing a real challenge and looking for the right person to join our adventure.

No deje pasar esta oportunidad, inscríbase rápidamente si su experiencia y habilidades coinciden con lo que se indica en la siguiente descripción.

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 lands...