Arielle Drummond
Regulatory Affairs & Quality (Medical Devices)
- Role
- Vice President of Global Regulatory Affairs at OrganOx
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Arielle Drummond
Biomedical engineer with 15 years of experience in the medical device industry, with 5 years of FDA experience in the cardiovascular and digital health device space; Able to navigate the various premarket and postmarket medical device regulatory pathways, including device classification, 510(k), De Novo, premarket approval application (PMA), investigational device exemption (IDE), post approval studies, recalls, and complaints; Experience in directing device development process, including prototyping, preclinical studies, clinical studies, manufacturing, program management, regulatory strategy and submissions, quality management system and intellectual property.
Experience
Vice President of Global Regulatory Affairs
Jun 2024 — Present
Education
The University of North Carolina at Chapel Hill
MS, Biomedical Engineering
2002 — 2004
Carnegie Mellon University
Ph.D., Biomedical Engineering
2004 — 2008
Skills
- Matlab
- Medical Devices
- R&D
- Spectroscopy
- Biomaterials
- Bioengineering
- Biomedical Engineering
- Design of Experiments
- Experimentation
- Medical Imaging
- Solidworks
- Research
- Data Analysis
- Pre-Clinical Studies
- Biotechnology
- Research and Development (R&D)
- Fda
- U.s. Food and Drug Administration (Fda)
- Finite Element Analysis
- Ventricular Assist Devices
- Labview
- Leadership
- Grant Writing
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