Bruce McKean Email & Phone Number
Director of Regulatory @ Rimsys Regulatory Management Software
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Bruce McKean Location
- Boston, MA, US
Bruce McKean Work
- Director of Regulatory @ (January 2022 - Present)
- Director, Quality and Regulatory (Q and R) @ (July 2011 - January 2022)
- Sr. Q and R Manager - Quality and Regulatory Integrations @ Philips Healthcare - Patient Care and Clinical Informatics (PCCI) (January 2009 - July 2011)
- Quality System Manager @ Philips Healthcare - Ultrasound (January 2006 - January 2009)
- Sr. Quality Engineer @ Philips Medical Systems - Ultrasound (October 2001 - January 2006)
- Quality Engineer @ (October 2000 - October 2001)
- Quality Engineer @ (October 1997 - September 2000)
Bruce McKean Education
- University of Massachusetts Lowell
Bachelor’s Degree (College of Engineering, Industrial Technology)
Bruce McKean Skills
- Medical Devices
- ISO 13485
- FDA
- Validation
- ISO 14971
- Regulatory Affairs
- GMP
- Quality System
- Quality Auditing
- V&V
- 21 CFR Part 11
- Design Control
- CE marking
- CAPA
- 21 CFR
- Biomedical Engineering
- Corrective and Preventive Action (CAPA)
- Medical Device Directive
- Supplier Quality
- U.S. Food and Drug Administration (FDA)
- Cross-functional Team Leadership
- Quality Management
- U.S. Title 21 CFR Part 11 Regulation
- Verification and Validation (V&V)
- Engineering
- Sales
- Microsoft Excel
- Project Management
- Process Improvement
- Customer Service
- Corrective and Preventive Action Capa
- Cross Functional Team Leadership
- u.s. Food and Drug Administration Fda
- u.s. Food and Drug Administration
- Corrective and Preventive Action
Bruce McKean Summary
- Bruce McKean, based in Boston, MA, US, is currently a Director of Regulatory at Rimsys Regulatory Management Software. Bruce McKean brings experience from previous roles at Philips (formerly Philips Healthcare), Philips Healthcare - Patient Care and Clinical Informatics (PCCI), Philips Healthcare - Ultrasound and Philips Medical Systems - Ultrasound. Bruce McKean holds a Bachelor’s Degree in College of Engineering, Industrial Technology @ University of Massachusetts Lowell. With a robust skill set that includes Medical Devices, ISO 13485, FDA, Validation, ISO 14971 and more. Bruce McKean has 1 emails and 1 mobile phone numbers on RocketReach.
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