Sean Bundy Email & Phone Number
VP, Regulatory Affairs and Quality Assurance @ Foundation Medicine
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Sean Bundy Location
- Englewood, CO, US
Sean Bundy Work
- VP, Regulatory Affairs and Quality Assurance @ (October 2025 - Present)
- Vice President of Quality and Regulatory Affairs @ (November 2022 - October 2025)
- Chief Operating Officer @ (May 2020 - November 2022)
- Director of Regulatory and Quality @ (July 2018 - May 2020)
- Vice President Regulatory and Quality @ (July 2016 - July 2018)
- Director, Quality and Regulatory @ (January 2009 - July 2016)
- Regulatory Affairs Manager @ Cochlear Americas (January 2007 - January 2009)
- Clinical Studies Manager and Project Manager @ Cochlear Americas (January 2005 - January 2007)
- Systems Integration Engineer @ NetRegulus, Incorporated (January 2000 - January 2005)
- Clinical Business Systems Analyst @ Cochlear Corporation (January 1999 - January 2000)
Sean Bundy Education
- Edinburgh Business School, Heriot-Watt University
Master of Business Administration - MBA
2018-2022 - Cranfield University
Postgraduate diploma (Medical Technology Regulatory Affairs)
2009-2013 - University of Chicago
P.G. Certificate (Clinical Studies Management)
2006-2008
Sean Bundy Skills
- Project Management
- Manufacturing
- Program Management
- Biomedical Engineering
- Quality Assurance
- Regulatory Affairs
- Medical Devices
- Verification and Validation V&V
- Marketing
- ISO 14971
- Microsoft Excel
- Design Control
- ISO 13485
- CAPA
- FDA
- Product Development
- Customer Service
- Regulatory
- Support
- Regulatory Submissions
- Quality Management
- Development
- Regulatory Strategy Development
- Process Improvement
- Research
- Management
- Clinical Trials
- SQL
- Quality System
- Business Process Improvement
- Sop
- V&V
- Cross Functional Team Leadership
- Business Analysis
- u.s. Food and Drug Administration Fda
- Software Documentation
- Regulatory Requirements
- u.s. Food and Drug Administration
- Verification and Validation
Sean Bundy Summary
- Sean Bundy, based in Englewood, CO, US, is currently a VP, Regulatory Affairs and Quality Assurance at Foundation Medicine. Sean Bundy brings experience from previous roles at NeoGenomics Laboratories, HepQuant and Precision Biopsy, LLC. Sean Bundy holds a 2018 - 2022 Master of Business Administration - MBA @ Edinburgh Business School, Heriot-Watt University. With a robust skill set that includes Project Management, Manufacturing, Program Management, Biomedical Engineering, Quality Assurance and more. Sean Bundy has 2 emails and 1 mobile phone numbers on RocketReach.
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