Dawn Bowen-Bolles

Dawn Bowen-Bolles is a seasoned Regulatory Specialist at Position Health, LLC, where she has spent the past five years serving as the primary regulatory authority for a U.S. based medical device company distributing internationally. Despite joining the company without prior medical device experience, Dawn stepped into the role at full speed, navigating an FDA audit within her first six months. She established the organization’s entire regulatory filing system and quality management system, applying the discipline and precision she honed through years of legal and consulting work. In her role, Dawn oversees all regulatory communications with distributors and government agencies, handling everything from manufacturing and labeling compliance to domestic and international product registrations. Her involvement covers nearly every operational aspect of the business, ensuring products meet regulatory standards across jurisdictions. One of her most notable achievements was successfully guiding a premarket submission through clearance with the U.S. Food and Drug Administration—even as new cybersecurity requirements were introduced mid-filing. Working against tight deadlines and unfamiliar regulations, she delivered approval with minutes to spare, exemplifying her ability to break down complex challenges and drive them to completion. Dawn’s career spans more than four decades and includes work in food science, R&D, consulting, education, paralegal practice, and regulatory affairs. She holds two bachelor’s degrees from Michigan State University, a master’s degree in teaching, and a paralegal certificate from Loyola University Chicago, where she graduated with a 4.0 GPA. Now working remotely, Dawn brings structure and balance to her days—treating remote work like a traditional office schedule and protecting her weekends—while continuing to be a steady, trusted force in one of the most demanding corners of the healthcare industry.