VP, Regulatory Affairs and Quality Assurance
A seasoned Global Quality and Regulatory Compliance Executive with over two decades of leadership in the medical device industry. Tammy Lavery possesses deep expertise in securing FDA approvals, developing and implementing global regulatory strategies, and managing robust Quality Management Systems (ISO 13485, MDSAP). Her experience spans new product development, risk management (ISO 14971), clini...
Experience: 30+ years
Tammy Lavery provides regulatory consulting services to clients in:
This professional holds a Bachelor of Science from the University of Utah's College of Health, where they were recognized with the Dean's Outstanding Achievement Award. This strong academic foundation in a health-related field, combined with early recognition for excellence, provides a solid basis for their deep understanding of the scientific and clinical principles essential for navigating complex medical device regulations. Their education is a valuable asset for medtech companies seeking a consultant with both regulatory acumen and a fundamental grasp of health sciences.
This individual's record of high performance was evident early in their career, having been honored with the Dean's Outstanding Achievement Award upon graduating from the University of Utah. This academic distinction underscores a long-standing commitment to excellence and a rigorous, detail-oriented approach. Such recognition highlights a foundation of success that has continued throughout their professional career in the medtech industry.
As a holder of the prestigious Regulatory Affairs Certification (RAC) from RAPS, this professional demonstrates a certified, high-level of expertise and commitment to the regulatory field. Their background also includes experience with ASQ CQA audit principles, signifying a strong foundation in quality systems. These credentials reflect active engagement with leading industry bodies, ensuring their knowledge remains current and aligned with best practices in the global regulatory landscape.
With over two decades of experience, this executive has a distinguished career in global quality and regulatory affairs within the medical device industry. They have held progressively senior leadership roles, including VP and Senior Director, at notable companies such as Xcision Medical Systems, Owlet Baby Care, and Bard Access Systems. Their experience demonstrates a proven ability to lead global regulatory strategy, manage complex quality management systems (QMS), and guide new product development from concept to market launch. This extensive track record in both established medtech firms and innovative startups makes them a versatile and highly valuable strategic partner for companies at any stage of growth.
A seasoned Global Quality and Regulatory Compliance Executive with over two decades of leadership in the medical device industry. Tammy Lavery possesses deep expertise in securing FDA approvals, developing and implementing global regulatory strategies, and managing robust Quality Management Systems ...
Tammy Lavery offers medtech companies a powerful combination of executive-level strategic vision and hands-on regulatory execution, backed by 30 years of industry leadership. Her deep expertise spans the most challenging regulatory pathways, including 510(k), De Novo, and PMA submissions, for a wide range of complex devices such as cardiovascular, SaMD, and implantables (Class I-III). What truly distinguishes Tammy is her versatile experience, having served as a VP of RA/QA and a direct consultant, enabling her to effectively guide both startups and large corporations through the entire product lifecycle. She is a proven leader in developing global regulatory strategies for US, EU, and Canadian markets, managing robust ISO 13485/MDSAP compliant QMS, and securing critical market approvals, making her an invaluable asset for achieving commercial success.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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