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.
• QMS Training for Medical Devices: FDA QSR and ISO 13485:2016
• Implementing the EU’s New Medical Device Regulation (MDR 2017/745)
• Supply Chain Operations
• Supply Chain Planning
• Supply Chain Logistics
• Certificate - A Simple Guide to Virtual Assistance
• Fundementals of Project Management
• National Honor Society in Paralegal - Lambda Epsilon Chi
• Loyola University Chicago
• Kendall College
• National Louis University- M.A.
• The French Pastry School
• Michigan State University- B.S.
• Lambda Epsilon Chi National Honor Society in Paralegal Studies
• The Service Club of Chicago
• Common Threads
• The Anti-Cruelty Society
• Legal Aid Chicago
• The Service Club of Chicago
• Executive Condo Board Member
• (CAPE) Chicago Partnerships in Education
What do you attribute your success to?
My diverse background and expertise in project management across various fields have driven my success. Over more than four decades I've treated every task as a project—whether it's an FDA filing, $2.3 million dollar major capital planning, or teaching students. I break challenges down into actionable steps, remain disciplined, and communicate effectively, even under pressure. If overwhelmed, I allow myself a brief pause, then refocus on short-term goals while keeping the end result in mind. Discipline and focus are central to my approach, helping me stay the course despite criticism. I believe jobs are learning opportunities rather than personal definitions; even in less enjoyable roles, there’s always something valuable to gain. My unique combination of experiences is my greatest strength.
What advice would you give to young women entering your industry?
View each position as a chance to learn, rather than something that determines your identity, and prioritize developing robust organizational and project-management skills. Remain receptive to acquiring knowledge in new fields and leverage networking and volunteer activities to expand both your opportunities and your self-assurance.
What are the biggest challenges or opportunities in your field right now?
One of the biggest challenges in my field is the increasing complexity of regulations, including emerging requirements like cybersecurity in FDA premarket filings, and the impact of AI (Artificial Intelligence). At the same time, there’s real opportunity in remote work, which expands access to talent, strengthens networks for other working women, and allows us to connect with expertise and resources well beyond a single office.
What values are most important to you in your work and personal life?
The values I prioritize include discipline, persistence, and a strong project-oriented work ethic. Additionally, I am deeply committed to service and volunteerism, family, and the principle of lifelong learning.