Jaap L. Laufer
For over 30 years, Dr. Jaap Laufer has provided expert advice and helped hands-on to implement strategies towards achieving market approval and access of medical devices and drug device combination products, mainly in the US and Europe. For 7 years, he has been the Head of Clinical and Regulatory Affairs of Emergo, head-quartered in Austin, TX. Emergo is the largest, globally operating company in the medical devices field that provides a comprehensive spectrum of services covering all aspects of the entire life –cycle of medical technology products, including global consulting, product registrations and company representations in countries on all five continents, and compliance activities needed to maintain products on the market. (www.emergogroup.com).
Dr. Laufer teaches International Regulatory Affairs at the University of Southern California (USC) in Los Angeles. He is also a permanent advisor to the European Commission and to a well-known European Notified Body. He owns a small company in Switzerland that specializes in FDA compliance for non-US companies. Dr. Laufer was the European President of the Washington, DC based Regulatory Affairs Professional Society (RAPS) and in 1999 established the European Association of Authorized Representatives, a small but influential trade organization.
Dr. Laufer has been responsible for the successful design and implementation of regulatory and strategies for a large variety of medical devices invented, designed, developed and /or manufactured by small start-up to household-name corporations. Prior to joining Emergo he owned, then sold his Authorized Representative company based in the Netherlands. He held corporate positions in Regulatory and Clinical Affairs in Switzerland–based Lipomatrix (mammary implants), Pfizer Hospital products Europe (which included being on Pfizer’s the Business Development Board) and Abbott Laboratories (drugs). He also used to be an auditor for a Notified Body and is advisor to another one.
Dr. Laufer holds degrees in Pharmacy and Medicine from the University of Groningen, The Netherlands. He published numerous articles in his areas of expertise. He is married and has children in Irvine, CA and Tel Aviv.