GE Healthcare has announced that Mark Kramer, former Director of the Office of Combination Products at the U.S. Food and Drug Administration (FDA), has joined GE Healthcare as Vice President, Regulatory Affairs. Mr. Kramer brings over 17 years of experience from the FDA as well as insight on regulatory affairs and quality compliance relating to product development from various positions within the private industry sector.

"GE Healthcare has gained an important leader who possesses a global perspective on regulatory affairs that is unmatched in the medical device industry," said Dee Mellor, GE Healthcare's Chief Quality Officer. "As GE continues to develop innovative technologies that improve the entire patient experience, from early and more accurate diagnosis to better treatment and management of disease, Mark will provide the leadership that is necessary to ensure compliant best practices in the regulatory process."

Mr. Kramer will lead the regulatory function for medical devices across GE Healthcare and will work closely with global regulatory bodies to formulate strategic business plans. His in-depth knowledge of regulatory procedures and processes will further guide GE as it pursues next-generation technology, including device-biologic products, biomarkers and molecular medicine.
During his tenure at the FDA, Mr. Kramer most recently served as Director, Office of Combination Products. Prior to the creation of this new department in 2002, he previously served as Special Assistant to the Associate Commissioner for Planning; Director, Center for Devices and Radiological Health (CDRH) Staff College; Chief, Anesthesiology and Defibrillator Devices Branch; and Chief, Urology and Lithotripsy Devices Branch.

While in the private sector, Mr. Kramer held various regulatory and compliance positions, most recently as Vice President, Regulatory Affairs at EDAP Technomed, Inc. in the mid to late 1990s. He also served as a Senior Consultant at C.L. McIntosh & Associates and began his career as a Project Engineer and a Clinical Engineer at Cordis Corporation. He has a B.A. in mathematics from Rutgers University in New Jersey and a M.S. in Biomedical Engineering from Rensselaer Polytechnic Institute in New York. He holds a Certificate in Quality Management from George Washington University in Washington, D.C.

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