Elizabeth J. Haines is a senior director of regulatory and quality at Access Vascular, Inc., and an expert in the medical device field with more than two decades of experience. She has made a name for herself by leading regulatory initiatives, mentoring professionals, and embracing the latest technological innovations. Her academic journey began at Middlesex Community College, where she earned an associate degree in liberal arts and sciences in 2008. She later graduated summa cum laude from Northeastern University in 2014 with a Bachelor of Science in health management. To supplement her expertise, she has acquired numerous certifications, including an executive leadership certificate from Northwestern University, multiple certificates from Cornell University, and a certification in medical devices from RAPS University.
Ms. Haines’ career path reflects her commitment to excellence in regulatory affairs, particularly in the medical devices industry. Since 2024, she has served as senior director of regulatory and quality at Access Vascular, Inc. Her previous roles have included serving as vice president of global regulatory affairs at Transmedics, senior director of regulatory affairs at ZOLL Medical Corporation, and vice president of regulatory clinical quality at Conformis. Her extensive work across various medical device companies has provided her with a diverse and in-depth understanding of medical products, ranging from orthopedic implants and surgical instruments to women’s health and defibrillation ventilators.
One of Ms. Haines’ most remarkable career highlights came during her tenure at ZOLL Medical Corporation. While there, she played a crucial role in working with the Food and Drug Administration (FDA) and the Department of Defense to enhance the safety of oxygen containers used in military tanks. She also led efforts to adapt ZOLL’s internal regulatory protocols after the organization became classified as a class three medical device company, a status requiring greater scrutiny from the FDA. Under her leadership, ZOLL’s regulatory department grew from three employees to a global team of 38 members, and the organization’s global submissions rose to nearly 600 a year. Her passion for mentoring, developing regulatory systems, and streamlining processes left a lasting impact.
In addition to her professional success, Ms. Haines is a lecturer at Northeastern University, teaching courses on regulatory affairs, medical devices, and the legal aspects of clinical trials. She took on this role to help bridge the gap between academia and the real-world challenges of the regulatory field. She firmly believes in giving back to the community, particularly by preparing students to navigate the complexities of the medical device industry.
Ms. Haines is deeply involved in civic activities, particularly advocating for autism awareness and special education. Her 17-year-old son has autism, and she has been a strong advocate for his education and development since his diagnosis at age two. She emphasizes that individuals can achieve their dreams regardless of obstacles, a message she has instilled in her son. In addition, Ms. Haines volunteers at Strongwater Farm, furthering her mission of helping others.
Looking ahead, Ms. Haines sees her future in shaping the next generation of regulatory professionals and continuing to evolve the industry through her leadership. She plans to continue mentoring young professionals entering the medical device field, emphasizing the importance of humility, vulnerability, and building strong networks. Her teaching and mentorship are focused on guiding students to understand the regulatory environment’s challenges and opportunities.
In the next five to ten years, Ms. Haines hopes to remain deeply involved in advancing regulatory and clinical quality in the medical device field. She believes that embracing artificial intelligence and other technological advancements will enhance the industry’s efficiency, allowing for faster product development and more streamlined operations. However, she firmly believes that technology should not replace human workers but instead augment their abilities. This forward-thinking approach distinguishes Ms. Haines from her peers and highlights her dedication to innovation in regulatory affairs.
Ms. Haines also seeks personal fulfillment alongside her professional ambitions. She looks forward to continuing to pursue her hobbies, which include hiking, kayaking, swimming, and playing frisbee. Her son has expressed a desire for her to open a coffee shop where he can work, and she has supported this idea to foster independence and personal growth for him. Additionally, she has partnered with Access Vascular, Inc., to provide job opportunities for high school students and adults with disabilities, reflecting her ongoing commitment to giving back to her community.
Throughout her career, Ms. Haines has consistently attributed her success to the mentors who have guided her along the way. She particularly credits Marcy Jaqua, her long-time mentor, for providing invaluable advice and support. Ms. Haines also embraces a philosophy of “being uncomfortable with the comfortable,” recognizing that personal growth often comes from stepping outside one’s comfort zone. She encourages others to challenge the status quo, speak up, and express their opinions, even when it is difficult to do so. For her, success comes not from avoiding adversity but from tackling it head-on and being open to change.
Ranked eighth in the Top 25 Healthcare Psychology Leaders for Massachusetts in 2023, Ms. Haines continues to be a thought leader in the regulatory field. She regularly participates in webinars and panel discussions on using technology and artificial intelligence to improve regulatory and clinical quality. Her reputation as an expert in the field is solidified by her contributions to Math Medic’s expert panel, discussing the latest trends in medical devices, solidifying her reputation as an expert. Additionally, she takes great pride in mentoring her staff and helping them achieve their professional goals.
As she reflects on her journey, Ms. Haines remains grounded in her values and committed to her mission of advancing patient care, regulatory excellence, and personal growth. She advises others to stay true to themselves, pursue their dreams, and never lose sight of what they believe in. Her leadership, integrity, and devotion to her field inspire her colleagues, students, and the next generation of regulatory professionals.