Ms. Haines's role involves supporting product releases, implementing change improvements, and enhancing efficiency through lean and Six Sigma activities.
ANDOVER, MA, July 08, 2024 /24-7PressRelease/ -- Elizabeth Haines has been included in Marquis Who's Who. As in all Marquis Who's Who biographical volumes, individuals profiled are selected on the basis of current reference value. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all taken into account during the selection process.
Ms. Haines is a distinguished professional in regulatory, clinical and quality assurance, currently serving as the Senior Director of Regulatory and Quality at Access Vascular, Inc. since 2024. With over 20 years of experience, she has significantly contributed to maintaining compliance for medical device companies, ensuring adherence to documentation and manufacturing practices. Ms. Haines's role involves supporting product releases, implementing change improvements, and enhancing efficiency through lean and Six Sigma activities. Additionally, she is instrumental in development activities, including new indications, products, applications, and clinical trials.
Ms. Haines was the founder of BluePhire Consulting, where she serves as the chief executive officer, providing consulting services to startups. She also began teaching as a university lecturer at Northeastern University in 2023, where she imparts her extensive knowledge in Regulatory, Quality and Clinical to students.
Ms. Haines's career was marked by a series of previous notable roles. From 2023 to 2024, she was the Vice President of Global Regulatory Affairs at TransMedics. She also held the esteemed role of Vice President of Regulatory, Clinical, Quality at Conformis from 2022 to 2023. Earlier, Ms. Haines's tenure at ZOLL Medical Corporation between 2018 and 2022 stands out as a period of remarkable achievements as she rose from Associate Director of Regulatory Affairs to Director and Senior Director. During her tenure, Ms. Haines spearheaded the organization's adaptation to a new Pre-Market Authorization (PMA) Final Order for Automated External Defibrillators (AEDs) issued by the Food and Drug Administration. Under her leadership, the regulatory department expanded from three to over 35 global members, and she successfully implemented efficiency software systems that significantly enhanced job efficiency and compliance. As a result, the organization processed nearly 600 global submissions annually during her tenure.
In 2005, Ms. Haines began her profession as a Dossier Planning and Management associate at Bristol-Myers Squibb Medical Imaging. Subsequently, she landed positions with Hologic, Integra LifeSciences, Ocular Therapeutix Inc., and Sekisui. Just before being recruited by ZOLL Medical, she was a Senior Manager of Regulatory Affairs at Straumann from 2017 to 2018.
A graduate of Northeastern University, Ms. Haines earned a Bachelor of Science in Health Management, Summa Cum Laude, in 2014. She also holds an Associate Degree in Liberal Arts And Sciences from Middlesex Community College in 2008. Additionally, Ms. Haines holds several certifications that have bolstered her expertise, including serval certificates in Marketing Strategy, a Business Strategy, and Women in Leadership from Cornell University, as well as an executive leadership certificate from Northwestern University and a certificate in Medical Devices from RAPS University.
Outside her professional life, Ms. Haines is actively involved with various professional and civic-minded organizations such as the Regulatory Affairs Professional Society, Chief, and Strongwater Farm, where she volunteers. She also advocates for the autism community and special education as the mother of a 17-year-old son with autism.
In recognition of her contributions, Ms. Haines was ranked eighth among The Top 25 Healthcare Technology Leaders of Massachusetts for 2023. Her success is attributed to having the right mentors and being open to feedback and change. She also emphasizes the importance of vulnerability and adaptability in achieving one's goals. Looking ahead, Ms. Haines plans to focus on giving back to the regulatory, quality, and clinical environment by teaching at Northeastern University and supporting students entering the workforce. She has also become deeply involved in artificial intelligence and aims to support the upcoming generation entering the workforce by helping them succeed and achieve their aspirations through leadership, mentorship, and guidance.
About Marquis Who's Who®:
Since 1899, when A. N. Marquis printed the First Edition of Who's Who in America®, Marquis Who's Who® has chronicled the lives of the most accomplished individuals and innovators from every significant field of endeavor, including politics, business, medicine, law, education, art, religion and entertainment. Who's Who in America® remains an essential biographical source for thousands of researchers, journalists, librarians and executive search firms around the world. The suite of Marquis® publications can be viewed at the official Marquis Who's Who® website, www.marquiswhoswho.com.
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