Mark D. KramerPresident
Greater Milwaukee Area
President
Regulatory Affairs Executive
Director, Office of Combination Products, Office of the Commissioner
Special Assistant to the Assistant Commissioner for Planning
Director, CDRH Staff College
Chief, Anesthesiology and Defibrillator Devices Branch, CDRH
Vice President, Regulatory Affairs
Independent Regulatory Consultant
Senior Consultant
Chief, Urology and Lithotripsy Devices Branch, CDRH
Scientific Reviewer, Pacing and Electrophysiology Devices Branch
Clinical Engineer
Rensselaer Polytechnic Institute
Rutgers, The State University of New Jersey-New Brunswick
Regulatory Affairs Professional Society
The George Washington University
Recommendations: 0
Regulatory Strategy Development
Regulatory Affairs
Medical Devices
Combination Products
Pharmacueticals
Product Jurisdiction
FDA
Regulatory Submissions