Annie Wright Email & Phone Number
Senior Regulatory Affairs Manager @ Alere Inc.
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Annie Wright Location
- San Diego, CA, US
Annie Wright Work
- now Senior Regulatory Affairs Manager @
- 2021 -now Director, Regulatory Affairs and Quality Assurance @
- 2018 -now Associate Director, Regulatory Affairs and Quality Assurance @
- 2016 -now Senior Regulatory Affairs Manager @
- 2011 -2016 Regulatory Affairs Manager @
- 2000 -2011 Sr. RA and QA Engineer @
- 1988 -2000 Staff Engineer @
Annie Wright Education
- Santa Clara University
Bachelor's degree (Electrical and Electronics Engineering)
1983-1987
Annie Wright Skills
- Quality Improvement
- Computer Literacy
- Problem Solving
- Interpersonal Skills
- Auditing
- In Vitro
- ISO 14971, Risk Management
- IEC/EN 60601-1 Series
- 510(k) Submissions
- IDE, IRB
- Product Complaints
- MDRs
- C&R
- 21 CFR Part 820 (QSR)
- MDD, CE Marking process
- CAPA management
- ISO 13485
- FDA Regulations
- International Registrations
- Design Control
- Medical Devices
- CAPA
- V&V
- Quality System
- Product Development
- Product Safety
- 21 CFR
- FDA
- ISO 14971
- R&D
- Regulatory Requirements
- Manufacturing
- Digital Imaging
- Cross-functional Team Leadership
- Quality Assurance
- Six Sigma
- DICOM
- ISO
- Supplier Quality
- Medical Imaging
- Regulatory Affairs
- Product Launch
- Lean Manufacturing
- CE marking
- Validation
- Biomedical Engineering
- IEC 60601
- UL
- GMP
- 21 CFR Part 11
- Regulatory Submissions
- Change Control
- Hardware Diagnostics
- Design of Experiments
- Quality Auditing
- Design for Manufacturing
- Ce Marking Process
- Leadership
- Sales
- 21 Cfr Part 820 Qsr
- IDE
- QC
- Java
- IRB
- Engineering
- Cross Functional Team Leadership
- Iec/en 60601 1 Series
- Microsoft Excel
- Management
- Risk Management
- 510k Submissions
- Mdd
- Testing
- PowerPoint
- 510 Submissions
- 21 CFR Part 820
Annie Wright Summary
- Annie Wright, based in San Diego, CA, US, is currently a Senior Regulatory Affairs Manager at Alere Inc.. Annie Wright brings experience from previous roles at Wondfo USA, Drawbridge Health, Alere Inc. and Zest Anchors. Annie Wright holds a 1983 - 1987 Bachelor's degree in Electrical and Electronics Engineering @ Santa Clara University. With a robust skill set that includes Quality Improvement, Computer Literacy, Problem Solving, Interpersonal Skills, Auditing and more. Annie Wright has 2 emails and 2 mobile phone numbers on RocketReach.
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