Vice President, Clinical and Regulatory Affairs
MR. STIEGMAN MANAGES AND DIRECTS THE CLINICAL AND REGULATORY AFFAIRS DEPARTMENTS FOR MCRA AND ITS CLIENTS. Mr. Stiegman is responsible for management of approximately 15 clinical and regulatory professionals at MCRA. Mr. Stiegman leads the firm's submission process, regulatory strategy, analysis and development: from pre-clinical testing, to FDA submissions, to market approval and post commercialization. He also oversees the planning and execution of the clinical studies managed by MCRA's Clinical Research Organization.
Prior to joining MCRA in February 2006, Mr. Stiegman served as the Chief of the Orthopedic Devices Branch for US Food and Drug Administration. As Branch Chief, Mr. Stiegman managed a team of scientists, clinicians, and engineers in the regulation of all orthopedic devices marketed in the United States. In addition, Mr. Stiegman was responsible for overseeing all FDA guidance documents and FDA policy determinations for orthopedic devices marketed in the US. Furthermore, he assisted in and oversaw all integrity, compliance, and monitoring issues regarding the orthopedic industry in collaboration with the Office of Compliance.
Mr. Stiegman was also a member of several leveraging groups such as the Orthopedic Device Forum and Orthopedic Surgical Manufacturer Association, where he represented the FDA. As the head of the Orthopedic Devices Branch, Mr. Stiegman pursued the advancement and consistency in the regulation of all orthopedic devices. This was evident by the pursuit of reclassifying several types of orthopedic devices, developing guidance documents on state-of-the-art orthopedic devices, and educating and assisting the orthopedic community in the regulatory strategies to get devices to market.
Prior to becoming Branch Chief, Mr. Stiegman was a reviewer in the Orthopedic Devices Branch where he was the team leader on many state-of-the-art spinal technologies. He was a leader in the field of artificial disc replacements, nucleus replacements, posterior stabilization systems, and many of the current widely used fusion spinal systems. He authored a guidance document for industry on spinal systems indicated for fusion, and he also developed documents that assisted companies in getting other devices to market such as artificial disc replacements, nucleus replacements, and posterior stabilization systems. Mr. Stiegman received his Bachelor in Science at Tulane University in Biomedical Engineering and his Master in Science at Clemson University in Bioengineering with a focus on biomaterials and biomechanics.