Anne Paulussen is a seasoned regulatory affairs expert with over a decade of experience spanning in vitro diagnostics (IVDs), combination products, and biotechnology. She specializes in strategic regulatory guidance for combined submissions of investigational drugs with investigational devices, with a strong focus on Companion Diagnostics (CDx) under the EU In Vitro Diagnostic Regulation (IVDR).
Anne has successfully guided start-ups bringing their IVDs to the EU market, and advised major pharmaceutical and diagnostic companies on Annex XIV IVDR applications. Her expertise extends to global regulatory strategy, FDA engagement, and clinical trial compliance and she is also an experienced speaker and trainer at industry conferences such as EMWA, RAPS and Healixia Clinical Trial conference.
Currently, Anne serves as Quality, Regulatory, and Clinical Affairs Director at Flen Health, overseeing a team navigating global regulatory challenges. As co-chair of RAPS Belgium LNG and a member of EMWA’s Medical Device SIG, she actively contributes to the regulatory community.
With a passion for knowledge-sharing and regulatory excellence, Anne is dedicated to helping companies bring innovative combination products and diagnostics to market while ensuring compliance with evolving regulations.
