With over 18 years of experience in medical device product development and regulatory affairs, Kara brings extensive regulatory knowledge with orthopaedic and EU medical device regulation emphasis as well as comprehensive understanding of the overall medical device lifecycle. She specializes in international regulatory strategy and submissions, development and remediation of technical and regulatory documentation, clinical evaluation, and nonconformity and additional information request responses.
Kara Budor holds a Master of Science and a Bachelor of Science in biomedical engineering from the University of California, Davis, and the University of Iowa, respectively.
Prior to joining MCRA in 2021, Kara was the Regulatory Manager for a privately held orthopaedic manufacturer where she led the Regulatory department in US and international regulatory strategy development and plan execution. In addition, she wrote and reviewed technical documentation including technical files and clinical evaluation reports, worked with team members to address nonconformities and additional information requests for over 50 countries, conducted new market due diligence, reviewed labeling and marketing material, and was involved with notified body and authorized representative transfers as well as EU MDD to MDR transition efforts.
Overview
At MCRA, Kara Budor is Director, International Regulatory Affairs and primarily focuses on international regulatory strategy and submissions for various device types including, but not limited to, orthopaedics, spine, dental, imaging, respiratory, general surgery, and biologics. Kara works with clients and colleagues on regulatory strategy, analysis, and development; submissions and interactions with regulatory bodies; and design, review, and implementation of documentation and testing.