Tara J. Burnett, MS, RAC, CQA, CQM/OE, has built a successful career in regulatory affairs and quality assurance for medical device manufacturing, dedicating more than two decades to the field. She currently serves as the senior vice president of regulatory affairs and compliance at Monarch Medical Technologies. Her responsibilities include implementing scalable, compliant systems that are easy for employees to follow while fostering a culture of regulatory excellence through coaching and mentoring.
Ms. Burnett’s career at Monarch Medical Technologies has been marked by significant leadership roles since she joined the company in 2021. She previously served as vice president of regulatory affairs and senior vice president of compliance from 2022 to 2024 and as director of regulatory affairs and senior vice president of compliance from 2021 to 2022. Before joining Monarch, she was the director of quality at Tekni-Plex Inc. from 2017 to 2021. From 2007 to 2021, she worked as a consultant in regulatory affairs, where she found great satisfaction in helping smaller manufacturers establish quality systems and secure regulatory approvals.
Earlier in her career, Ms. Burnett was the quality assurance manager at SensoryEffects from 2015 to 2017 and director of quality and regulatory at Midmark Corporation from 2013 to 2015. In 2014, she also served as an instructor for the regulatory affairs certificate program at Colorado State University. At Baxter Healthcare Corporation, formerly Baxa Corporation, she was senior manager of regulatory affairs in 2013 and regulatory affairs manager from 2009 to 2013. She began her career at Daavlin, serving as a regulatory affairs service manager from 2003 to 2009. Beyond her professional roles, Ms. Burnett has also served as an advocate for CASA: A Voice for Children Inc., supporting child welfare initiatives.
Ms. Burnett worked to build a strong academic foundation in preparation for her career, earning a Bachelor of Applied Science in business management with a focus on microcomputer applications from Siena Heights University, graduating magna cum laude in 2010. She furthered her education with a Master of Science in regulatory affairs for drugs, biologics, and medical devices from the D’Amore-McKim School of Business at Northeastern University in 2012, also graduating magna cum laude. Ms. Burnett holds multiple certifications, including an SQF certification and the Six Sigma Green Belt certification from the Management & Strategy Institute. She is an ASQ-certified manager of quality/organizational excellence, a certified quality auditor from the American Society for Quality, and completed the regulatory affairs certification program from the Regulatory Affairs Professionals Society.
In light of her impressive undertakings, Ms. Burnett has received several accolades, including the MVP of the Year Award from Monarch Medical Technologies in 2024, a certificate of completion and award for ISO 9000:2000 series auditor/lead auditor training in 2005, and multiple dean’s list honors at Northeastern University, Siena Heights University, and Jackson Community College. She was also inducted into Phi Theta Kappa at Jackson Community College.
Ms. Burnett attributes her success to the values instilled by her family, who motivated her to pursue a career where she could make a meaningful impact. Looking to the future, she aspires to become a distinguished leader in the medical device industry by building effective regulatory and quality teams that support manufacturers globally. Ms. Burnett is also committed to fostering growth within Monarch Medical Technologies while mentoring emerging leaders and engaging with industry networks to shape future best practices.