Sean Bundy
- Role
- Neogenomics Laboratories at Foundation Medicine
- Location
- Englewood, CO, US
- LinkedIn followers
- 500 followers
Research & DevelopmentView LinkedIn profile
About Sean Bundy
Knowledgeable, skilled, and resourceful Regulatory Affairs and Quality Executive…
Experience
Neogenomics Laboratories
Present
Education
University of Chicago
P.G. Certificate, Clinical Studies Management
2006 — 2008
Cranfield University
Postgraduate diploma, Medical Technology Regulatory Affairs
2009 — 2013
Edinburgh Business School, Heriot-Watt University
Master of Business Administration - MBA
2018
Skills
- Software Documentation
- Sop
- Medical Devices
- Fda
- Regulatory Strategy Development
- V&V
- Business Process Improvement
- Capa
- Iso 13485
- Quality Management
- Cross-Functional Team Leadership
- Design Control
- Project Management
- Regulatory Requirements
- Iso 14971
- Manufacturing
- Clinical Trials
- Regulatory Affairs
- Verification and Validation (V&V)
- Biomedical Engineering
- U.s. Food and Drug Administration (Fda)
- Program Management
- Process Improvement
- Regulatory Submissions
- Product Development
- Marketing
- Quality System
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