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Regulatory & Quality Lead – AI IVD Diagnostics

spotlabMADRID, Comunidad de Madrid, Spain
On-site Full-time

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Experience Level

Mid to Senior

Qualifications

We are looking for candidates who possess:Proven experience in regulatory affairs, particularly within the IVD sector. Strong understanding of the CE marking process and IVDR regulatory requirements. Experience in developing and maintaining a Quality Management System aligned with ISO 13485.Excellent communication skills to collaborate effectively with notified bodies and regulatory authorities. Ability to coordinate risk management and post-market surveillance processes. A passion for innovation and a commitment to ensuring the highest quality in healthcare solutions.

About the job

Join us on an exciting journey as we tackle real-world challenges in the field of AI diagnostics!

At SpotLab, we are at the forefront of AI innovation, empowering biopharmaceutical research and diagnostic advancements with our state-of-the-art AI solutions. As a burgeoning startup specializing in AI-driven medical diagnostics, we seek a talented individual who can enhance our processes and adeptly navigate regulatory landscapes to achieve compliance.

With a strong foundation in quality and regulatory affairs, SpotLab has achieved significant milestones, including acquiring the In Vitro Medical Device Manufacturer License from the Spanish Medicines Agency, establishing a Quality Management System compliant with ISO 13485 standards, securing CE Marking for two AI diagnostic products under the IVDD, and obtaining ISO 27001 certification. We are committed to evolving our regulatory approach to keep pace with the dynamic landscape.

In this role, you will have the opportunity to make a meaningful impact by helping to certify AI models for microscopy images in hematology and infectious diseases, ultimately transforming patient care on a global scale.

SpotLab has garnered over 10 international awards, including the prestigious Seal of Excellence from the European Union. Our multidisciplinary team champions gender parity and brings together professionals from diverse backgrounds, including engineers, medical doctors, clinical researchers, and business strategists.

About spotlab

SpotLab is an innovative AI laboratory that specializes in advancing biopharmaceutical research and diagnostic solutions. We leverage cutting-edge AI technologies to provide reliable medical diagnostics, ensuring that we remain at the forefront of innovation in healthcare.

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