Brad Hossack, international vice president, international regulatory affairs, Boston Scientific Corporation. Hossack has been in regulatory for more than 20 years, spending the past 11 years at Boston Scientific. His focus has been on international markets, with responsibility for all international regulatory activities outside the US. Hossack’s regulatory career has covered the areas of hazardous goods, medical devices, diagnostics, pharmaceutical and biologics products, always focusing on international markets. Hossack holds a BSc (Hons) from the University of Guelph, Canada.
Patrick Johnson, senior director, regulatory affairs, Medtronic Neuromodulation, has more than 20 years experience in the pharmaceutical and medical device industries, across a variety of pharmaceutical dosage forms and medical devices including combination products. Johnson has more than 15 years of regulatory experience with responsibilities spanning local, state, federal and international regulatory agency requirements. He is currently responsible for deep brain stimulation and emerging therapies within Medtronic Neuromodulation.
Mark Kramer, RAC, president, Regulatory Strategies Inc., has more than 20 years experience in the medical device industry, including 17 years with the US FDA, where he held a variety of review and management positions in the Center for Devices and Radiological Health’s Office of Device Evaluation. He served as the director of the Office of Combination Products from its establishment in 2002 until 2007. Most recently, Kramer served as an executive in regulatory affairs at GE Healthcare before starting his own consulting company. He holds an MS in biomedical engineering from Rensselaer Polytechnic Institute. Kramer serves on the Board of Directors of the Regulatory Affairs Professional Society (RAPS), and is the founder and chair of the Wisconsin RAPS Chapter.