Karla Fields Email & Phone Number
Regulatory Affairs Program Manager @ Accuray
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Karla Fields Location
- Elizabethtown, IN, US
Karla Fields Work
- 2022 -now Regulatory Affairs Program Manager @
- 2021 -2022 Sr. Regulatory Affairs Specialist @
- 2019 -2021 Regulatory Affairs Consultant and Contractor @ Modis @ Cook Medical & Zimmer Biomet
- 2018 -2019 Regulatory Affairs Consultant and Contractor @
- 2018 -2018 Regulatory Affairs Consultant and Contractor @ Treximo / Planet Pharma @ Pfizer
- 2016 -2018 Regulatory Affairs @ Catalent Biologics (Cook Pharmica)
- 2014 -2016 Manager - QA and RA Post Market Survellience, Field Actions @
- 2012 -2014 Regulatory Affairs Specialist @
- 2012 -2012 Regulatory Affairs @
- 2012 -2012 Regulatory Affairs Contractor @
- 2007 -2012 Regulatory Affairs Specialist @
- 2005 -2007 Loan Closer @ HSBC / Decision One Mortgage
- 2003 -2005 Sr. Staffing Supervisor @
- 2000 -2003 Regulatory Affairs Associate @
- 2000 -2001 Regulatory Assistant Temporary-Fenwal Regulatory Affairs @
- 1998 -1999 HR and Recruiting Account Manager @ Great Lakes International
- 1994 -1998 Human Resources Manager @ Omega Associates
- 1993 -1994 HR Administrator @ New Resources Corporation
Karla Fields Education
- University of Phoenix
Bachelor's of Science (Business Management)
- University of Phoenix
General Management Certificate
Karla Fields Skills
- FDA GMP
- Talent Management
- Budgeting
- Human Resources (HR)
- Project Management
- Program Management
- Regulatory Compliance
- Quality Management
- Manufacturing Operations Management
- Training and Development (HR)
- Recruiting
- Global Regulatory Compliance
- Problem Solving
- Portfolio Planning
- Organization Skills
- Market Assessments
- Communication
- Workable Solutions
- European Union
- Regulatory Agencies
- Marketing Compliance
- Technical Presentations
- Creative Problem Solving
- Regulatory Documentation
- 510(k)
- Regulatory Affairs
- Regulatory Submissions
- FDA
- Medical Devices
- ISO 13485
- CE marking
- Sop
- Leadership
- Regulatory Requirements
- CAPA
- Change Control
- Design Control
- Quality System
- V&V
- GMP
- Validation
- 21 CFR Part 11
- Quality Auditing
- Clinical Trials
- ISO 14971
- Pharmaceutical Industry
- Biopharmaceuticals
- Biotechnology
- Computer System Validation
- GLP
- Lifesciences
- Quality Assurance
- Technology Transfer
- GCP
- 21 CFR
- Hardware Diagnostics
- Life Sciences
- Corrective and Preventive Action (CAPA)
- U.S. Food and Drug Administration (FDA)
- U.S. Title 21 CFR Part 11 Regulation
- Standard Operating Procedure (SOP)
- Verification and Validation (V&V)
- Has Errors
- PowerPoint
- Sales
- Training
- Great
- Verification And Validation V&V
- Corrective And Preventive Action Capa
- U.S. Food And Drug Administration Fda
- Standard Operating Procedure Sop
- u.s. Food and Drug Administration
- Corrective and Preventive Action
- Standard Operating Procedure
- Verification and Validation
Karla Fields Summary
- Karla Fields, based in Elizabethtown, IN, US, is currently a Regulatory Affairs Program Manager at Accuray. Karla Fields brings experience from previous roles at Accuray, Modis @ Cook Medical & Zimmer Biomet, The Evanston Group, Inc.@ J&J and Treximo / Planet Pharma @ Pfizer. Karla Fields holds a Bachelor's of Science in Business Management @ University of Phoenix. With a robust skill set that includes FDA GMP, Talent Management, Budgeting, Human Resources (HR), Project Management and more. Karla Fields has 2 emails and 2 mobile phone numbers on RocketReach.
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