Engineer (Dipl.-Ing) in Bioprocess technology and Biochemistry. Worked as a product specialist in immunohematological products and plasma products with Sanquin blood bank, Amsterdam. QA and RA manager at IVD firm in the Netherlands. Worked for over 6 years as audit team leader, dossier reviewer and project manager at KEMA Medical Notified Body. Acted as IVD product specialist and Principal Certification Manager at DEKRA Certification, Business Line Medical (6 years). After this, worked for 4 years as a regulatory consultant, Alex now has the position of Head of the Notified Body IVD at BSI.