2017 -2019 Vice President, Global Regulatory Affairs @ Johnson & Johnson Vision
2016 -2017 Sr. Director, Regulatory Affairs @
2014 -2016 Group Director, Regulatory Affairs @
2011 -2014 Director, Regulatory Affairs @ Biomet
1997 -2011 Director, Regulatory Affairs @
1996 -1997 Development Engineer @ Zimmer, Inc.
1993 -1996 Project Engineer @
Laura Williams Education
Indiana Wesleyan University
MS (Management)
2009-2010
Purdue University
BS (Mechanical Engineering)
1988-1992
Laura Williams Skills
Validation
Clinical Trials
CAPA
Orthopedic
V&V
FDA GMP
Product Launch
Regulatory Requirements
R&D
Regulatory Affairs
Quality Auditing
FMEA
21 CFR
Biotechnology
Quality Assurance
Complaint Management
CE marking
Cross-functional Team Leadership
Regulations
Regulatory Submissions
Product Development
Quality System
Change Control
GMP
ISO 14971
FDA
ISO 13485
Biomedical Engineering
Medical Devices
ISO
Design Control
PMA
Manufacturing
Root Cause Analysis
Medical Device Directive
Orthopedics
Commercialization
21 CFR Part 11
Microsoft Excel
Laminates
First Article Inspection
Corrugate
Continuous Improvement
Material Selection
Solidworks
Corrective and Preventive Action Capa
Technical Writing
Polymers
Failure Mode and Effects Analysis Fmea
u.s. Food and Drug Administration Fda
Prototype
Labeling
Team Leadership
Food Safety
Manufacturer
SharePoint
Sales
Closures
Food and Beverage
9001/13485/14971/16106
Lean Manufacturing
Medical Terminology
Consumer and Healthcare Products
Process Validation
Package Validation
Packaging
ASTM standards
5s
Sbs
ArtiosCAD
Cross Functional Team Leadership
Testing and Analysis
Foam
Product Marketing
Microsoft Word
Rigid and Flexible Plastics
Java
PowerPoint
Microsoft Office
Verification and Validation V&V
Corporate Branding
Leadership
Business Development
Bill of Materials
Packaging Equipment
MS Office
Technology Transfer
Strategic Planning
Iopp
Equipment Calibration
u.s. Food and Drug Administration
Corrective and Preventive Action
Failure Mode and Effects Analysis
Verification and Validation
Laura Williams Summary
Laura Williams, based in United States, is currently a Vice President, Regulatory Affairs at CooperVision. Laura Williams brings experience from previous roles at NEASE BAND BOOSTERS INC, Exactech, Johnson & Johnson Vision and Johnson & Johnson Vision Care, Inc.. Laura Williams holds a 2009 - 2010 MS in Management @ Indiana Wesleyan University. With a robust skill set that includes Validation, Clinical Trials, CAPA, Orthopedic, V&V and more. Laura Williams has 4 emails and 2 mobile phone numbers on RocketReach.
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