James Shearn Email
Director, Regulatory and Quality Compliance @ STERIS
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James Shearn Location
- Alcester, GB
James Shearn Work
- 2023 - now Director, Regulatory and Quality Compliance @
- 2019 - now Managing Director @ RegCentrix Ltd.
- 2021 - 2022 Vice President Regulatory Affairs and Quality Assurance @
- 2020 - 2021 Head of Regulatory Affairs @
- 2010 - 2019 UK Regulatory Affairs Manager @
- 2008 - 2010 UK RA Product Approval Manager @
- 2006 - 2008 Regulatory and Quality Manager @
- 2005 - 2006 Acting Regulatory Affairs Manager @
- 2000 - 2005 Project Manager @
- 1998 - 2000 Electronics Engineer @
- 1997 - 1998 Manufacturing Engineer @
- 1996 - 1997 EBME Biomedical Engineer @ Edgware General Hospital
- 1995 - 1995 EBME Biomedical Engineer @ Chase Farm Hospital, Enfield
James Shearn Education
- University of Hertfordshire 1995
James Shearn Skills
- Regulatory Affairs
- Medical Devices
- Medical Informatics
- Diagnostics
- Infusion
- Regulatory Submissions
- Design Control
- ISO 13485
- Quality Systems
- CAPA
- Quality Assurance
- CE marking
- Risk Management
- Quality System
- Informatics
- Product Development
- R&D
- Medical Device Directive
- ISO 14971
- V&V
- Medical Diagnostics
- Cross-functional Team Leadership
- Electronics
- Microsoft Excel
- Technical Support
- Cross Functional Team Leadership
- Java
- Continuous Improvement
- SAN
James Shearn Summary
- James Shearn, based in Alcester, GB, is currently a Director, Regulatory and Quality Compliance at STERIS. James Shearn brings experience from previous roles at RegCentrix Ltd., Oncimmune and Abbott Diabetes Care. James Shearn holds a University of Hertfordshire. With a robust skill set that includes Regulatory Affairs, Medical Devices, Medical Informatics, Diagnostics, Infusion and more. James Shearn has 2 emails on RocketReach.
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