José E. Cabrera

Biography

Mr. Cabrera is Vice President of Regulatory Affairs & Quality Affairs and is Somahlution's Management Representative. He joined Somahlution in March of 2014 and has been developing global regulatory affairs strategies and Quality Systems compliant with US FDA and European regulations. Mr. Cabrera served in the U.S. Army as a Combat Medic with the 101st Airborne Division in Ft. Campbell KY. After graduating from the University of Dallas with a B.A. in Cell Biology in 1994, he went on to teach science courses in high school and college. Since 2001, Jose managed several clinical studies that involved Class III implantable medical devices and prepared two PMA submissions for a Dutch ophthalmology device company entering into the US market. After receiving FDA approval for the new technology devices, Mr. Cabrera manage international regulatory affairs and act as Quality System liaison for all of Bausch + Lomb’s businesses in Latin America. The portfolio included pharmaceuticals, medical devices and nutritional products. He provided regulatory affairs support for manufacturing facility in Porto Alegre Brazil. He also worked for BIOMET in Palm Beach Gardens as the Global Regulatory Affairs Lead where he was responsible for new product registrations, global surveillance, and medical device reporting. Most recently, Mr. Cabrera worked as a consultant to small and large organizations providing support in authoring clinical, quality and regulatory procedures and policies and supporting ISO 13485 implementation and CE marking of medical devices for Europe.

Research Interest

Mr. Cabrera is Vice President of Regulatory Affairs & Quality Affairs and is Somahlution's Management Representative. He joined Somahlution in March of 2014 and has been developing global regulatory affairs strategies and Quality Systems compliant with US FDA and European regulations. Mr. Cabrera served in the U.S. Army as a Combat Medic with the 101st Airborne Division in Ft. Campbell KY. After graduating from the University of Dallas with a B.A. in Cell Biology in 1994, he went on to teach science courses in high school and college. Since 2001, Jose managed several clinical studies that involved Class III implantable medical devices and prepared two PMA submissions for a Dutch ophthalmology device company entering into the US market. After receiving FDA approval for the new technology devices, Mr. Cabrera manage international regulatory affairs and act as Quality System liaison for all of Bausch + Lomb’s businesses in Latin America. The portfolio included pharmaceuticals, medical devices and nutritional products. He provided regulatory affairs support for manufacturing facility in Porto Alegre Brazil. He also worked for BIOMET in Palm Beach Gardens as the Global Regulatory Affairs Lead where he was responsible for new product registrations, global surveillance, and medical device reporting. Most recently, Mr. Cabrera worked as a consultant to small and large organizations providing support in authoring clinical, quality and regulatory procedures and policies and supporting ISO 13485 implementation and CE marking of medical devices for Europe.