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Regulatory & Quality Lead – AI IVD Diagnostics

🇪🇸 Spain

Management

Finance

Machine Learning

Regulatory & Quality Lead – AI IVD Diagnostics

from 🇪🇸 Spain

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:

  1. Lead theCE marking plan and execution to certify AI-based IVD diagnostic products.

  2. Act as the company’sPRRC (Person Responsible for Regulatory Compliance) forIVD products.

  3. OwnIVDR regulatory strategy and align product roadmap, evidence, and documentation to regulatory timelines.

  4. Evolve and maintain ascalable QMS (ISO 13485-aligned).

  5. Drivetechnical documentation and conformity assessment readiness.

  6. Implementrisk management andPMS/vigilance processes.

  7. Coordinate withnotified bodies and authorities.

  8. Work with AI/engineering to ensure compliance withEU AI Act obligations.

  9. Support regulatoryaudits, internal audits, and supplier evaluation meetings

  • Experience inSaMD (Software as a Medical Device) regulatory frameworks and compliance activities.

  • Experience withEU medical device regulations, includingIVDR (EU) 2017/746 and/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 requirements specifically forAI-based systems in the medical sector.

  • Excellentanalytical skills, with strongattention to detail and clear, structuredcommunication (written and verbal).

  • Advanced English and Spanish proficiency (verbal and written).

  • Ability to thrive in afast-changing environment and collaborate effectively withmultidisciplinary teams.

  • University degree inEngineering, Medicine, Pharmacy, Biotechnology, Law, or another relevant scientific discipline.



by @maxrusakovic