Jessica Smith, PhD, RAC
Jessica Smith, PhD, RAC, is a senior regulatory and quality executive in the medical technology industry with more than 25 years of experience in global healthcare and life sciences. She is known for her expertise in regulatory affairs, quality systems, clinical strategy, and enterprise transformation across medical devices and combination products. Throughout her career, she has held executive leadership roles overseeing global regulatory strategy, FDA and international submissions, compliance frameworks, and large-scale quality management systems for complex, multinational organizations.
Her career includes senior leadership positions across major MedTech companies including Integra LifeSciences, Becton Dickinson, Hillrom, and C. R. Bard. In these roles, she led global regulatory and quality organizations spanning hundreds of professionals across multiple regions, driving regulatory strategy, product approvals, post-market compliance, and operational excellence. She also contributed to major organizational transformations, including mergers and acquisitions due diligence, process optimization, and the development of scalable global quality systems supporting large product portfolios and multi-billion-dollar business units.
Jessica earned her academic foundation at the University of Utah John and Marcia Price College of Engineering, where she completed both her engineering studies and later a PhD in bioengineering. Beginning her career in civil engineering, she transitioned into bioengineering and regulatory affairs while balancing professional advancement with raising a family. A former collegiate gymnast and scholarship athlete, she brings a leadership philosophy centered on resilience, authenticity, and team development. Recently retired from executive practice, she now focuses on mentoring, advisory work, and supporting the next generation of leaders in regulatory and quality disciplines.
• Regulatory Affairs Certification (RAC)
• University of Utah John and Marcia Price College of Engineering - PhD
• Athletic Scholarship
• Team co-captain of NCAA Division 1 National Championship gymnastics team
• NCAA All-American Gymnast 1988, 1990
• University of Utah
What do you attribute your success to?
I attribute my success to building strong teams and helping others achieve their goals, particularly through guiding complex regulatory affairs processes such as FDA submissions, testing, and product approvals that can take years to complete. I take pride in consistently doing quality work and leading by example, which has naturally resulted in career growth without actively seeking promotion. My leadership style has also been shaped by significant life experiences, including being raised by a single mother, moving frequently as a child, my years as an athlete, becoming a single mother, and the loss of my daughter, Maya. These experiences have strengthened my resilience, empathy, and ability to support others through challenge and change.
What advice would you give to young women entering your industry?
My advice to young women entering my industry is to stay resilient and consistently take pride in doing good work, even when the role isn’t ideal. Be authentic, transparent, and kind to yourself—people value honesty and can easily see through inauthenticity. Don’t feel pressured to model yourself after a certain type of leader; strong leadership can be quiet, empathetic, and grounded in treating people as human beings. Focus less on chasing titles and more on showing up with integrity and doing your best, as opportunities often come naturally from that mindset. Also, give yourself grace—mistakes are inevitable, and what matters most is how you respond, learn, and move forward.
What are the biggest challenges or opportunities in your field right now?
The biggest challenges in my field include navigating complex global regulatory requirements, coordinating across multiple time zones, managing demanding schedules with heavy meeting loads, and leading large, distributed teams effectively. At the same time, a key opportunity lies in guiding products through lengthy regulatory pathways—working through detailed development, testing, and documentation processes to ultimately achieve approvals and bring meaningful products to market.
What values are most important to you in your work and personal life?
The values most important to me in both my work and personal life are resilience, authenticity, transparency, kindness, and empathy. I also place a strong emphasis on taking pride in my work and consistently leading by example, ensuring that my actions reflect the standards and values I expect from others.
Locations
Integra LifeSciences
Salt Lake City, UT 84124