Kelley Breheim Email & Phone Number
Principal Regulatory Affairs Specialist @ Admedus
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Kelley Breheim Location
- Saint Paul, MN, US
Kelley Breheim Work
- 2026 - now Principal Regulatory Affairs Specialist @
- 2025 - 2026 Director of Regulatory Affairs @
- 2024 - 2024 Principal Regulatory Affairs Specialist, MDR @
- 2020 - 2024 Sr. MDR Regulatory Project Manager @
- 2016 - 2020 Principal Regulatory Affairs Specialist @
- 2016 - 2016 Senior Regulatory Affairs Specialist @
- 2015 - 2016 Principal Regulatory Affairs Specialist @
- 2015 - 2015 Principal Regulatory Affairs Specialist @
- 2014 - 2015 Senior Regulatory Affairs Specialist @ St. Jude Medical
- 2009 - 2014 Regulatory Affairs Specialist @
- 2007 - 2008 Senior Marketing Specialist @
Kelley Breheim Education
- University of St. Thomas
MBA (Marketing Management)
2002 - 2006 - University of Wisconsin - River Falls
BS (Business Administration, French)
1997 - 2001
Kelley Breheim Skills
- Medical Devices
- FDA
- Registration
- 510 K
- Regulatory Affairs
- CE marking
- Cardiac Surgery
- Regulatory Submissions
- Regulatory Strategy
- Healthcare
- ISO 14971
- CAPA
- Design Control
- PMA
- V&V
- Regulatory Requirements
- Medical Device Directive
- Quality System
- ISO 13485
- 21 CFR
- Commercialization
- Validation
- Biomedical Engineering
- Product Launch
- Clinical Trials
- GMP
- Strategy
- U.S. Food and Drug Administration (FDA)
- Corrective and Preventive Action (CAPA)
- Marketing Strategy
- Sales
- Regulatory
- Pharmaceutical Industry
- Microsoft Office
- u.s. Food and Drug Administration Fda
- Social Media
- Corrective and Preventive Action Capa
- Customer Service
- u.s. Food and Drug Administration
- Corrective and Preventive Action
Kelley Breheim Summary
- Kelley Breheim, based in Saint Paul, MN, US, is currently a Principal Regulatory Affairs Specialist at Anteris Technologies. Kelley Breheim brings experience from previous roles at Contraline, Teleflex and Coloplast. Kelley Breheim holds a 2002 - 2006 MBA in Marketing Management @ University of St. Thomas. With a robust skill set that includes Medical Devices, FDA, Registration, 510 K, Regulatory Affairs and more. Kelley Breheim has 2 emails and 1 mobile phone numbers on RocketReach.
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Kelley Breheim
Principal Regulatory Affairs Specialist
Saint Paul, MN, US
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