Rebecca Gilbert
Regulatory Affairs Manager at Aspen Surgical, RAC-Devices
- Role
- Regulatory Affairs Manager at Aspen Surgical
- Location
- Denver, CO, US
- LinkedIn followers
- 500 followers
About Rebecca Gilbert
Materials Science and Engineering alumna from Georgia Tech with an emphasis on soft materials and strong interest in the areas of medical devices, sustainability, and clean energy. Interested in finding ways to combine a passion for people, the planet, and technology and seeks to figure out how we can learn to innovate to serve humanity while also preserving our home for future generations.
Experience
Regulatory Affairs Manager
Feb 2025 — Present · Caledonia, MI, US
Accountable for all sustaining efforts for the regulatory affairs team for FDA Class I and II surgical products, including cross-functional collaboration with Engineering, Quality, Labeling, and Commercialization teams to ensure regulatory compliance and company success. Leads and manages a team of four reports to balance workloads and achieve department- and company-wide goals and objectives.Individual emphasis on integrating new acquisitions into the Aspen enterprise, acting as regulatory subject matter expert for legal manufacturer changes under EU MDR, and international product registrations and UDI database compliance.
Education
St. Cloud State University
Master of Science - MS, Regulatory Affairs and Services
2022 — 2024
Georgia Institute of Technology
Bachelor of Science - BS, Materials Science and Engineering
2012 — 2016
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