Regulatory specialist Dawn Bowen-Bolles built FDA compliance systems for medical device company

Dawn Bowen-Bolles, a regulatory specialist at Position Health, LLC, became the company’s primary regulatory authority and helped build its quality and filing systems after joining without prior medical device experience. Her work included navigating an FDA audit early on and clearing a complex premarket submission that faced new cybersecurity requirements mid-filing. Why it matters: - Dawn Bowen-Bolles’ work sits at the center of whether Position Health, LLC can sell medical products in the U.S. and abroad. - Her role affects FDA compliance, product safety, labeling, registrations and distributor communications across multiple markets. - The company’s ability to move submissions through changing rules depends on that regulatory infrastructure. What happened: - Dawn Bowen-Bolles has spent the past five years as a Regulatory Specialist at Position Health, LLC in Lake Forest, Illinois. - She serves as the company’s primary regulatory authority for a U.S.-based medical device business that distributes internationally. - She joined the company without prior medical device experience and quickly took on a high-responsibility role. - During her first six months, she navigated an FDA audit. - She also established the company’s foundational regulatory filing system and quality management system. - She successfully guided a complex premarket submission through clearance with the U.S. Food and Drug Administration. The details: - Dawn Bowen-Bolles oversees regulatory communications with distributors and government agencies. - Her work covers manufacturing compliance, labeling standards, and domestic and international product registrations. - The submission she managed became more difficult when new cybersecurity requirements were introduced mid-filing. - She delivered the approval with minutes to spare. - Her career spans more than four decades across food science, regulatory consulting, paralegal practice, teaching, healthcare compliance, legal work, consulting, education, and research and development. - She holds two bachelor’s degrees from Michigan State University, a master’s degree in teaching, and a paralegal certificate from Loyola University Chicago. - Dawn Bowen-Bolles graduated from Loyola University Chicago with a 4.0 GPA. - She also has experience managing multi-million-dollar capital planning initiatives. - She now works remotely while keeping a structured daily routine that mirrors a traditional office environment. Between the lines: - Dawn Bowen-Bolles’ background in law, teaching and food science likely helped her adapt fast in a heavily regulated industry. - Her project-management approach appears to be a core advantage in environments where rules change midstream. - She sees rising regulatory complexity, including cybersecurity demands and the growing influence of artificial intelligence on compliance systems and documentation standards. - Remote work is also opening the field to broader talent pools and wider professional networks, especially for women. - Her comments on pausing, resetting focus and returning to short-term priorities suggest a practical method for handling regulatory pressure. What’s next: - Dawn Bowen-Bolles says young women entering regulatory and healthcare roles should treat each position as a learning opportunity. - She encourages early investment in organizational and project-management skills, plus networking and volunteer work. - Position Health, LLC will likely continue facing evolving FDA and international requirements as product and compliance standards shift. - Dawn Bowen-Bolles plans to keep working in regulatory affairs while maintaining service, family and lifelong learning as core priorities. The bottom line: - Dawn Bowen-Bolles has turned a steep on-ramp into a central compliance role, helping Position Health, LLC stay audit-ready and globally compliant as regulations get harder to navigate.