Kim Colasanti Email & Phone Number
Associate Director Regulatory Affairs @ Baxter Healthcare Corporation
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Kim Colasanti Location
- Liverpool, NY, US
Kim Colasanti Work
- Associate Director Regulatory Affairs @ (December 2023 - Present)
- Sr Manager Regulatory Affairs @ (March 2022 - December 2023)
- Regulatory Affairs Manager @ (October 2020 - March 2022)
- Lead Regulatory Engineer @ (May 2020 - October 2020)
- Sr. Software Project Manager @ (March 2019 - May 2020)
- Sr. Manager, Quality Systems @ (April 2016 - October 2018)
- Software Quality Assurance Manager @ (December 2009 - April 2016)
- Senior Software Quality Assurance Engineer @ (March 2004 - December 2009)
- Senior Software Engineer @ (November 2000 - March 2004)
- Senior Software Engineer @ (October 1999 - November 2000)
- Project Lead @ Polaris Library Systems (September 1998 - October 1999)
- Software Engineer @ Coherent Research, Inc. (July 1996 - November 1997)
Kim Colasanti Education
- Syracuse University
MS (Computer Science)
1997-1998 - Syracuse University
BS (Computer Science)
1992-1997 - Onondaga Community College
A (Math and Science)
1990-1993
Kim Colasanti Skills
- 21 CFR
- 21 CFR Part 11
- Agile Methodologies
- Biomedical Engineering
- Business Process Improvement
- CAPA
- Corrective and Preventive Action (CAPA)
- Cross-functional Team Leadership
- Defect Tracking
- Design Control
- EDI 845
- FDA
- FMEA
- Failure Mode and Effects Analysis (FMEA)
- IEC 62304
- ISO
- ISO 13485
- ISO 14971
- ISO Standards
- Medical Devices
- Process Improvement
- Product Development
- Project Management
- Quality Assurance
- Quality Auditing
- Quality System
- R&D
- Requirements Analysis
- Research and Development (R&D)
- Risk Management
- SAP Projects
- SDLC
- Software Configuration Management
- Software Development
- Software Development Life Cycle
- Software Documentation
- Software Engineering
- Software Project Management
- Software Quality Assurance
- Technical Leadership
- Technical Writing
- Test Methodologies
- Testing
- U.S. Food and Drug Administration (FDA)
- Use Case
- Validation
- Development
- Software
- Corrective And Preventive Action Capa
- Research And Development R&D
- Microsoft Office
- Process Development
- Cross Functional Team Leadership
- Customer Service
- U.S. Food And Drug Administration Fda
- Failure Mode And Effects Analysis Fmea
- Project Planning
- SQL
- Design
- Cfr
- Quality Systems
- Failure Mode and Effects Analysis
- Research and Development
- Corrective and Preventive Action
- u.s. Food and Drug Administration
Kim Colasanti Summary
- Kim Colasanti, based in Liverpool, NY, US, is currently a Associate Director Regulatory Affairs at Baxter Healthcare Corporation. Kim Colasanti brings experience from previous roles at Baxter Healthcare Corporation. Kim Colasanti holds a 1997 - 1998 MS in Computer Science @ Syracuse University. With a robust skill set that includes 21 CFR, 21 CFR Part 11, Agile Methodologies, Biomedical Engineering, Business Process Improvement and more. Kim Colasanti has 1 emails and 1 mobile phone numbers on RocketReach.
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