Melissa has over 25 years of experience in medical device quality systems and regulatory compliance. While her core expertise lies in regulatory affairs, I have worked across the full product lifecycle—from development through post-market activities – bringing a holistic perspective to compliance and innovation. She excels in cross-functional collaboration, leveraging deep regulatory knowledge to support new product development, assess design changes, and ensure alignment with global standards.
Her leadership style is grounded in collaborative empowerment, fostering high-performing teams through mentorship, clear communication, and strategic vision. She is passionate about developing talent and creating a culture of accountability, continuous learning, and excellence. She leads with transparency and integrity, encouraging proactive problem-solving and cross-functional engagement to drive results.
With extensive experience in Quality Management System (QMS) development and improvement, she has guided companies through ISO certification and regulatory inspections, demonstrating a comprehensive understanding of compliance and quality assurance. She is a certified lead auditor, and has successfully prepared clients for and conducted internal and supplier audits, and hosted FDA and notified body inspections with confidence and professionalism.
As Director of Regulatory Affairs at MEDIcept, Melissa is a key member of the executive management team, responsible for both day-to-day regulatory operations and long-term strategic planning. She leads the Regulatory Affairs Team with a focus on client success, operational excellence, and regulatory innovation. She provides strategic consulting and education services, helping clients navigate complex regulatory landscapes and build sustainable compliance frameworks.
Prior to joining MEDIcept in 2025, I served as a quality and regulatory consultant at RQM+, and held leadership roles in Quality and Regulatory at Peregrine Surgical, Tiercel Surgical, HR Pharmaceuticals, DENTSPLY, Unilife Medical Solutions, and Lonza Biologics. These roles have shaped my ability to lead diverse teams, manage change, and deliver impactful regulatory strategies across a variety of organizational structures and product portfolios.
I hold a B.S. in Biology and an MBA from Mount Saint Mary’s College, as well as a graduate certificate in Regulatory Affairs from Hood College. I am an active member of RAPS and serve in various community volunteer roles, reflecting my commitment to both professional excellence and civic engagement.
