Bernard Bosley Email & Phone Number
Vice President Regulatory Affairs and Quality @ Enterra Medical, Inc.
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Bernard Bosley Location
- Minneapolis, MN, US
Bernard Bosley Work
- 2022 -now Vice President Regulatory Affairs and Quality @
- 2019 -2022 Consultant @ Koumu Engineering, Inc.
- 2017 -2019 Executive Director Regulatory and Clinical Affairs @
- 2014 -2017 Consultant: Regulatory Affairs - Risk Management - Software Quality - HIPAA @
- 2014 -2016 Consultant: Regulatory Affairs @
- 2014 -2014 Consultant Quality Systems, Compliance, and Regulatory Affairs @ Evergreen Medical Technologies
- 2011 -2014 Director, Quality Systems @ QiG group
- 2009 -2011 Risk Management Consultant @ Koumu Engineering Inc.
- 2009 -2009 Consultant @ RCRI, Minneapolis, Minnesota
- 2002 -2009 Risk Management @
- 1999 -2002 Product Assurance Manager @
- 1996 -1999 Reliability Engineer @
Bernard Bosley Education
- University of Minnesota
BSME (systems, dynamics adn thermodynamics of compressible and incompressible fluid flow)
1981-1985 - University of Minnesota Instatute of Technology
Bachelor of Science (BS) (Mechanical Engineering)
Bernard Bosley Skills
- ISO 13485
- Medical Devices
- Quality System
- FDA
- Design Control
- ISO 14971
- FMEA
- Biomedical Engineering
- CAPA
- Regulatory Affairs
- Design of Experiments
- Quality Control
- Reliability Engineering
- Regulatory Submissions
- ISO
- GMP
- Six Sigma
- Manufacturing
- Minitab
- PMA
- Quality Systems
- CE marking
- QSR
- Quality Engineering
- Reliability
- Statistics
- U.S. Food and Drug Administration (FDA)
- Risk Assessment
- Failure Mode and Effects Analysis (FMEA)
- Corrective and Preventive Action (CAPA)
- Pacemakers
- Cardiac
- DOE
- cGMP
- PMA-S
- 510k
- V
- PMAs
- Consulting
- Regulatory
- Solutions
- Engineering
- Corrective And Preventive Action Capa
- U.S. Food And Drug Administration Fda
- Failure Mode And Effects Analysis Fmea
- R&D
- u.s. Food and Drug Administration
- Failure Mode and Effects Analysis
- Corrective and Preventive Action
Bernard Bosley Summary
- Bernard Bosley, based in Minneapolis, MN, US, is currently a Vice President Regulatory Affairs and Quality at Enterra Medical, Inc.. Bernard Bosley brings experience from previous roles at Koumu Engineering, Inc., Nuvectra, Inspire Medical Systems and Medtronic. Bernard Bosley holds a 1981 - 1985 BSME in systems, dynamics adn thermodynamics of compressible and incompressible fluid flow @ University of Minnesota. With a robust skill set that includes ISO 13485, Medical Devices, Quality System, FDA, Design Control and more. Bernard Bosley has 2 emails and 2 mobile phone numbers on RocketReach.
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