Experienced manager of medical device manufacturing business and medical device start up.Proven track record in general management, sales, marketing and distribution. Successful training, motivation and management of in-house salesforce and outside distributors. Regulatory Affairs experience (medical devices) both in the creation of national standards (AAMI) and implementation at the corporate level (FDA and ISO Quality Systems). Hands-on international experience in all aspects of import and export business, new market entry strategies, and international distribution. Represented U.S. manufacturers in Europe, Asia, and Latin America in commercial and regulatory negotiations, trade shows and business missions. Strong knowledge US Federal trade, business promotion, and regulatory programs. Excellent written and verbal communication skills, including effective public speaking.Specialties: Lived and studied in Japan.Member, Federal trade advisory committe on medical devices (ITAC 3). Current US government security clearance.Personal: Married, two children. Avid hiker and outdoorsman. Black Belt in Jujutsu. HAM radio operator.