Moritz Lübke

Regulatory Specialist at Boule Medical AB

Moritz Lübke is an experienced professional in quality assurance and regulatory affairs within the IVD (in vitro diagnostics) sector. Currently serving as a Regulatory Specialist at Boule Diagnostics AB since August 2025, Lübke has previously held multiple key positions, including Product Lifecycle Quality Manager and Risk Manager at Cepheid, where responsibilities included managing quality assurance for IVD tests, supporting IVDR conversions, and ensuring ISO-compliant risk management processes. Prior roles encompass a background in research and teaching at esteemed institutions such as Karolinska Institutet and Bonn University, culminating in a Ph.D. in Developmental Neurobiology. With a strong foundation in both scientific research and product management, Lübke has demonstrated expertise in project leadership, regulatory compliance, and risk management throughout a comprehensive career.

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Boule Medical AB

Boule is a diagnostic company that develops, manufactures and sells systems and consumer products for hematology.


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51-200

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