Bruce Waldon

Background

About Bruce Waldon

An experienced medical device Quality and Regulatory leader who has worked as a quality and regulatory specialist, manager, and director with FDA Class I, II, and devices and global device regulations and registrations. An effective leader who fosters a collaborative team environment to support the career goals of colleagues and provide a mentoring relationship to impart skills and knowledge to coworkers.More than 10 years of experience with cardiovascular support devices, to include pacing devices, electrophysiology products, and the CardioWest/SynCardia total artificial heart. Led the team that obtained the first CE Mark for a biventricular mechanical circulatory support device in 1998. An excellent regulatory writer with experience preparing FDA premarket notifications (510(k)s) and premarket approval (PMA) modules, EU documentation under the MDD, AIMD, MDR, and technical documentation for other countries and regions to support product approval submissions and product changes. Years of experience serving as a Quality and/or Regulatory representative on product design development teams for new products and product design changes for a variety of devices and risk classifications, from Class I medical exam gloves to a Class total artificial heart. A Certified Medical Device Auditor and ISO 13485 Lead Auditor dedicated to continuous improvement and adept at quality system creation, evaluation, and improvement.Adept at national and global medical device regulatory strategy and planning, and other key regulatory competencies as demonstrated through the attainment of a Master of Science degree in Regulatory Science and a RAPs Regulatory Affairs Certification (RAC) for medical devices.