Clinical Product Development Professional

As a results-driven professional with expertise spearheading the vision, development, and launch of revenue-producing opportunities in the medical device industry, I am currently looking for my next challenge. I offer exceptional experience in product development, clinical development, regulatory affairs, commercialization, and global launch. With my broad experience and hands-on approach to team building and management, I am confident in my ability to drive new business and increase total revenues for you and your team. Highlights of my experience include: ** Management, team building, and leadership expertise. ** Excellent product development experience with several U.S. and international patents and regulatory submissions for U.S. [IDE/PMA/510(k)] and EU [CE Mark] approvals. ** Proven capacity to ensure operational excellence at all levels while pioneering new technologies, partnerships, and revenue streams. ** Expert in all aspects of product management; experience creating manufacturing facilities, establishing distributing networks, and developing launch strategies in the U.S. and abroad. ** Unique international business experience combined with a personal commitment to diversity; Native American (registered status) with significant international business experience..

Clinical Regulatory Affairs