Broad experience in medical device innovation, research and development. Responsible for managing project plans, designing preclinical trials, from concept and inception to implementation and execution, including post approval surveillance, data analyses, within the rigor of regulatory and compliance oversight. Maintain expertise on applicable disease states in regards to device implantation across multiple franchises including interventional cardiology, neurology, urology and gastrointestinal/endoscopy. Technical, scientific, medical writing expertise in support of preclinical, clinical and scientific processes as well as in support of regulatory submissions. Comprehensive knowledge of SOP, GLP, USDA, FDA and AAALAC regulatory requirements for compliance oversight.