Medical device regulatory compliance strategist, providing support to medical device startup businesses and established companies for regulatory and quality strategies for rapid commercialization of innovative medical devices. Support clients with agile quality management systems implementation, with a special focus on start-up companies that require significant support and training. Experience with many key aspects of quality management, including document and design controls, design transfer, supplier controls, management reviews, and internal audits. Experienced regulatory researcher supporting regulatory strategy for platform technologies and preparing regulatory submissions, including FDA 510(k) Submissions, Pre-submissions (Q-Subs), De Novo, and Breakthrough Device Designation Requests. Enjoy working with dynamic teams whose values inspire constant innovation and drive to provide effective and high quality solutions that improve people’s quality of life.