Quality and Regulatory Manager for Health AI Products
Quality and Regulatory Manager for Health AI Products
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Job Description
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 cuttingedge 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 bring to market the first AI models for microscopy images in hematology and infectious diseasespioneering 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:
Contribute to the companys regulatory strategy for AI products in the medical sector
Support the CE Marking process for In Vitro Medical Devices including artificial intelligence algorithms for medical diagnosis
Ensure conformity assessment processes and technical documentation meet EU regulations (MDR/IVDR/EU AI Act)
Verify declarations of conformity and technical documentation are complete and uptodate
Implement and maintain effective postmarket surveillance systems
Oversee necessary corrective and preventive actions according to quality management procedures
Act as the contact point for regulatory authorities on compliance matters
Ensure appropriate risk assessment and mitigation measures for all products
Review and evaluate productrelated incidents and establish communication channels with authorities
Collaborate on health authorization applications and clinical studies supervision
Maintain regulatory competence and ensure staff training on requirements
Collaborate with the AI team to ensure products comply with the EU AI Act
Support regulatory audits internal audits and supplier evaluation meetings
Job requirements
University degree in Engineering Medicine Pharmacy Law or relevant scientific discipline
Minimum 2 years in regulatory affairs and quality management for medical devices
Strong understanding of EU MDR 2017/745 and IVDR 2017/746 regulations
Excellent analytical abilities attention to detail and communication skills
Experience in SaMD (Software as a Medical Device) regulation
Ability to interpret and apply regulatory requirements for AI systems in the medical sector
Advanced English and Spanish (verbal and written)
Ability to work in a fastchanging environment with multidisciplinary teams
Nice to have: Knowledge of emerging AI regulations in healthcare especially the EU AI Act
All done!
Your application has been successfully submitted!
Required Experience:
Manager
Employment Type
Full-Time
