Scott Wright Email & Phone Number
Founder, President and CEO and Project SME - Regulatory Affairs and Quality Management @ A Wright Path Inc.
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Scott Wright Location
- Pittsburgh, PA, US
Scott Wright Work
- now
- 2014 -2015 Project Team SME- RA and QA @
- 2013 -2014 Executive Consultant @
- 2013 -2013 Independent Quality and Regulatory Affairs Consultant @ Independent Quality and Regulatory Affairs Consultant
- 2011 -2013 Principal Regulatory and Quality Advisor @
- 2009 -2011 Sr. Regulatory Affairs Engineer @
- 2006 -2009 Regulatory Associate @
- 2005 -2006 Client Manager and Assessor @
- 2005 -2005 Quality Assurance Engineer @
- 2015 -now Founder, President and CEO and Project SME - Regulatory Affairs and Quality Management @
- 2008 -2009 Quality Assurance Engineer (Medical Division) @
Scott Wright Education
- CCAC
Scott Wright Skills
- CAPA
- Quality System
- ISO 13485
- FDA
- Medical Devices
- V&V
- Quality Assurance
- Validation
- Regulatory Affairs
- Quality Management
- Regulatory Requirements
- Root Cause Analysis
- Regulatory Submissions
- Regulatory Filings
- Global Regulatory Compliance
- Cross-functional Team Leadership
- Design Control
- Design Controls
- ISO 9001
- JPAL
- CMDR
- TGA
- MDD
- Verification and Validation
- Due Diligence
- Lead Assessor
- Usability and Human Factors
- Design Assurance
- Combination Products
- Process Validation
- GMP
- Device Registration and Listing
- Warning Letter/483 Support
- Technical File/Design Dossier
- Complaint Management
- Adverse Event Reporting
- Quality System Training
- Technical File/Design Dossier - CE Marking
- 21 CFR (Part 4/211/803/806/820)
- 510k/PMA
- Supplier Development/Evaluation/Audit
- Regulatory Remediation Activity
- Internal Audits/Mock Regulatory Audit
- ROW Product Registration
- Risk Management (ISO 14971)
- FMEA
- Regulatory Impact Analysis/Assessment
- Regulatory Strategy Development
- Team Leadership/Team Building
- Pharmaceutical Industry
- Microsoft Word
- Cross Functional Team Leadership
- 21 Cfr Part 4/211/803/806/820
- CE marking
- Program Management
- Regulatory
- Sales
- Risk Management Iso 14971
- Microsoft Office
- Management
- Strategic Planning
- 21 CFR
- Risk Management
Scott Wright Summary
- Scott Wright, based in Pittsburgh, PA, US, is currently a Founder, President and CEO and Project SME - Regulatory Affairs and Quality Management at A Wright Path Inc.. Scott Wright brings experience from previous roles at Qualira, Teleflex Incorporated, QA/RA Consulting Group, Inc. and Independent Quality and Regulatory Affairs Consultant. Scott Wright holds a CCAC. With a robust skill set that includes CAPA, Quality System, ISO 13485, FDA, Medical Devices and more. Scott Wright has 2 emails and 5 mobile phone numbers on RocketReach.
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