Regulatory Affairs and Quality Assurance Professional with over 16 years of experience in the Medical Devices, In-Vitro Diagnostics and Biologics field. This includes working with various companies that develop and manufacture complex electrical and mechanical instrumentation. An organized and effective manager with primary career focus on Regulatory Affairs and Quality Assurance implementation. Possess extensive knowledge of medical device products through all phases of development and manufacturing. Extensive experience obtaining applicable regulatory registrations within the FDA (CBER/CDRH) and other International Health Authority markets i.e. EU, Japan, Canadian (CAMCAS), Mexico and South America. An effective and motivational team player with a consistent track record in delivering bottom line results, improving time to market as well as enhancing regulatory and quality knowledge to key internal customers within the organization.