Darlene Welsh Email & Phone Number
Sr. Director, Regulatory Affairs @ Integra LifeSciences
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Darlene Welsh Location
- New York, NY, US
Darlene Welsh Work
- Sr. Director, Regulatory Affairs @ (November 1991 - Present)
Darlene Welsh Skills
- ISO 13485
- FDA
- CE marking
- CAPA
- ISO 14971
- Design Control
- Change Control
- Regulatory Requirements
- Quality System
- Medical Device Directive
- V&V
- FDA GMP
- Biomaterials
- PMA
- 21 CFR
- Regulatory Submissions
- Regulatory Affairs
- Medical Devices
- GMP
- Validation
- 21 CFR Part 11
- GLP
- Biologics
- IND
- Technology Transfer
- GxP
- Quality Auditing
- Sop
- Biomedical Engineering
- Trackwise
- Commercialization
- GCP
- Aseptic Processing
- Computer System Validation
- Biotechnology
- Biopharmaceuticals
- CMDCAS
- R&D
- Lifesciences
- Clinical Development
- Post Market Surveillance
- Complaint Management
- Biocompatibility
- Cross-functional Team Leadership
- U.S. Title 21 CFR Part 11 Regulation
- Verification and Validation (V&V)
- Research and Development (R&D)
- Corrective and Preventive Action (CAPA)
- Verification and Validation V&V
- Regulatory
- Corrective and Preventive Action Capa
- Research and Development R&d
- Cross Functional Team Leadership
- Research and Development
- Verification and Validation
- Corrective and Preventive Action
Darlene Welsh Summary
- Darlene Welsh, based in New York, NY, US, is currently a Sr. Director, Regulatory Affairs at Integra LifeSciences Corporation. With a robust skill set that includes ISO 13485, FDA, CE marking, CAPA, ISO 14971 and more. Darlene Welsh has 2 emails and 4 mobile phone numbers on RocketReach.
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Top Integra LifeSciences Employees
Robert Davis
EVP and President, Tissue Technologies
Princeton, NJ, US
Raymond Turner
Corporate Vice President and Chief Medical Officer
Greenville, SC, US
Amichai Vardi
VP Quality, Integra Lifesciences
New York, NY, US
Steve Powick
Senior Vice President, Global Marketing
Flemington, NJ, US
Vincent Cafiso
Vice President, Quality Compliance and QMS
New York, NY, US
Jason Dickinson
Senior Vice President Supply Chain
Buffalo Grove, IL, US
Benjamin Byers
Vice President, Global Strategic Marketing
Easton, MA, US
Jami Segota
VP, Deputy General Counsel
Rocky Hill, NJ, US
Lea Knight
EVP and Chief Financial Officer
Princeton, NJ, US
Ruth Fleming
Vice President of Commercial Sales Operations
Princeton, NJ, US
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