Prior to joining Goodwin in 2007, Mr. Heller was chair of the FDA Department at WilmerHale. Before that, he spent almost 10 years in the FDA’s Chief Counsel’s office, where he was actively involved in offensive and defensive litigation, including drug and device cases. During his last six years with the FDA, Mr. Heller was the Associate Chief Counsel for Medical Devices, responsible for the legal aspects of the agency's combination product, device enforcement, premarket notification, investigational device exemption, reclassification and premarket approval programs. He also was involved in the development of the Safe Medical Devices Act of 1990 while on detail to the office of the chairman (Senator Edward M. Kennedy) of the Senate Committee on Labor and Human Resources.
Before joining the FDA, Mr. Heller was with the Federal Trade Commission for eight and a half years. He focused on the regulation of food, drug and device advertising. Mr. Heller has received several awards for excellence for his work at both the FDA and FTC.