Mr. Rajapaksa joined Berlin Heart Inc. in September 2009 as Manager Quality Assurance and has since been promoted to the position of Vice President, Regulatory, Quality and Technical Services. He has overall responsibility for the Company’s quality system, Service department and Regulatory compliance. He plays an integral role in developing regulatory strategy for getting FDA approval for EXCOR® product line.
Dudley has more than 30 years of professional experience, knowledge and skills in the medical device industry. Prior to joining Berlin Heart, Dudley worked in several Medical device Companies, such as Mallinckrodt Medical Inc. (currently Merit Medical Systems Inc.), NovoSci (formally Jostra Corp, TMP/ Surgmedics) and West Advanced Injection Systems as a Pre- Production Quality Engineer, Sr. Quality Engineer and Quality Assurance & Regulatory Manager.
Dudley earned his Master of Science degree in Industrial Engineering at the University of Oklahoma in 1986 and he also holds a master’s degree in Mechanical engineering from Patrice Lumumba People’s Friendship University, Moscow, Russia (formerly USSR).
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