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 * standards, CE Marking for two AI diagnostic products under the IVDD, and ISO * 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 *-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
Job requirements
Experience in
SaMD (Software as a Medical Device)
regulatory frameworks and compliance activities.
Experience with
EU medical device regulations
, including
IVDR (EU) **
and/or MDR (EU) **.
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.
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📌 Regulatory & Quality Lead Ai Ivd Diagnostics (Madrid)
🏢 Spotlab
📍 Madrid