Dr. Clauss has over 40 years of experience spanning from International Regulatory Affairs (EMEA, FDA, EU National Global development) to new product development and Quality Assurance/ ISO certifications.
Louis served as a Resident Biologist in Public Hospitals before moving to the Multinational Health Care Industry both in the Medical Devices field and in Pharmaceuticals (Institut Mérieux, now Sanofi Aventis; Dow Corning; Boston Scientific; Clintec; Becton Dickinson; Baxter). He was the Global Director Regulatory Affairs for New Product Development, BioScience, for Baxter Healthcare Corporation. He has led the development of pharmaceuticals, stents, implantable devices, and biotherapeutics, including biosimilars. Louis directed Medical Device regulatory programs in the U.S. and Europe, including regulatory strategies, new product licenses and life cycle management as well as obtaining CE marking for hundreds of products.
Louis has been involved in over 100 regulatory submissions and agency meetings with EMA and FDA. He has over 70 publications and conference presentations and is a member of numerous professional associations.
Louis holds a Masters degree in Bio-Pharmacy from Paris VI University, a PhD in Pharmacy from Paris V University, and a degree in Business administration (IAE). He is a registered Qualified Person in Europe.