Holly Ramirez Rac
About Holly Ramirez Rac
Holly Ramirez Rac is a Senior Principal Regulatory Affairs Specialist with extensive experience in regulatory affairs across various companies, including Medtronic and Boston Scientific. She has a strong background in supporting Class III US Combination Products and possesses wide-ranging international experience, particularly in EU and Japan submissions.
Current Role at SurModics
Holly Ramirez Rac serves as a Senior Principal Regulatory Affairs Specialist at SurModics, a position she has held since 2020. In this role, she focuses on regulatory strategies and compliance for medical devices, contributing her expertise to ensure that products meet necessary regulatory standards. Her work is based in Eden Prairie, Minnesota.
Previous Experience at Medtronic
Holly Ramirez Rac worked at Medtronic in various capacities, including as a Principal Regulatory Affairs Specialist from 2017 to 2020 and as a Senior Regulatory Affairs Specialist from 2015 to 2017. During her time at Medtronic, she gained significant experience in regulatory submissions and compliance for medical devices, enhancing her skills in the field.
Regulatory Affairs Background at Boston Scientific
Holly served as a Senior Regulatory Affairs Specialist at Boston Scientific from 2009 to 2015. Her role involved navigating complex regulatory requirements and supporting the development and submission of medical devices, which contributed to her extensive knowledge in the regulatory landscape.
Education and Expertise
Holly Ramirez Rac earned her Bachelor of Applied Science (B.A.Sc.) degree from the University of Minnesota-Twin Cities, completing her studies from 2000 to 2005. Her educational background laid the foundation for her career in regulatory affairs, where she has developed expertise in areas such as EU compliance, Class III US Combination Products, and Japan submission processes.
International Regulatory Experience
Holly possesses wide-ranging international regulatory experience, including extensive work with EU regulations, Japan submissions for Class IV devices, and support for global regulatory compliance. Her skills encompass Design Dossier preparation, Notified Body Transfers, and Quality Management System audits, making her well-rounded in the field of regulatory affairs.