Huong T.
Global Regulatory Affairs
- Role
- Regulatory Affairs Manager at embecta
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Huong T.
Experienced Regulatory Affairs professional with a demonstrated history of working in the medical device industry and a Master of Science (M.Sc.) in Biomedical Engineering. Diverse expertise in high class and multi-component medical devices consisting of hardware, software, biologics, and accessories with a record of global regulatory submissions including FDA 510(k)’s, Pre-Submissions, EU Change Notification, and EU MDR Initial Submission. Combines regulatory affairs experience with a strong technical background in biomedical engineering, skills in technical writing/communication, and cross-functional collaboration. Driven, meets deadlines to support business goals, with an attention to detail who believes in continual development, leadership, and mentoring.
Experience
Regulatory Affairs Manager
Feb 2024 — Present
Education
St. Johnsbury Academy
High School Diploma
2009
University of Pittsburgh
Master of Science (M.Sc.), Biomedical Engineering
University of Pittsburgh
Bachelor of Science in Engineering, Biomedical Engineering
2013
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