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Laurie Hook Location
Redwood City, CA, US
Laurie Hook Work
2016 -now Founder and Strategic Advisor and Consultant @
2010 -2016 Vice President of Clinical and Regulatory Affairs @
2008 -2010 Vice President, Regulatory, Quality and Clinical Affairs @ Vibrynt, Inc.
2005 -2007 Director, Clinical and Regulatory Affairs and Director, Clinical Research and Clinical Regulatory Affairs @
2001 -2005 Clinical and Regulatory @
1989 -2001 Life Science Research Assistant @
Laurie Hook Education
University of California, Santa Cruz
B.A. (Biology)
Laurie Hook Skills
FDA
Clinical Trials
Medical Devices
Biomedical Engineering
Senior Executive Leadership
US/International Regulatory Affairs
Investor Relations
Board Relations
Advisory Boards
Medical Device Product Development
M&A analysis
Due Diligence
Highly Complex Clinical Trials
International Regulatory Bodies
KOL
Post Merger Integration
Physician Relations
Clinical/Regulatory Affairs
Defining Strategic Business Direction
Taking New Products to Market
Product Commercialization
Early Stage Company Development
Investor Presentations
510K, PMA, IDE, CE Mark, Shonin submissions
GLP, USDA, and NIH Pre-Clinical Research Guidelines
IDE, GCP, ISO 14155, TGA and MDD Clinical trial regulations
CFR QSRs, ISO 13485 Regulations & Certification
Healthcare
Cross-functional Team Leadership
Cross-cultural Communication Skills
Leading Development Teams
Relationship Building
Strategic Leadership
Driving Results
Acquisitions
Building In-House Clinical Teams
FDA/BIMO Audits
Statistical Data Analysis
Business Transition Planning
Regulatory Affairs
FDA Advisory Panels
Streamlining Of Processes
Global Delivery
CRA's
Collaborative Leadership
Medical Device R&D
Clinical Research
Product Management
C-Level Relationships
Investor Development
Microsoft Office
Business Strategy
Management
Business Development
Tga and Mdd Clinical Trial Regulations
Data Analysis
Building Unified High Performing Teams
Operational Excellence
Ce Mark
IDE
Nih Pre Clinical Research Guidelines
510k
Iso 14155
C Level Relationships
Course Correcting
Early Stage Startups
Iso 13485 Regulations and Certification
GLP
Project Management
Leadership Development
Trusted Business Advisor
Bringing Order to Chaos
M&a Integration
Cfr Qsrs
Shonin Submissions
USDA
PMA
Strategy Advisor
Us/International Relationships
Building/Leading Development Teams
Thought Leadership
Program Management
Board/Investor Relations
Cross Functional Team Leadership
Building in House Clinical Teams
GCP
Cross Cultural Communication Skills
Laurie Hook Summary
Laurie Hook, based in Redwood City, CA, US, is currently a Founder and Strategic Advisor and Consultant at Reedhook Consulting. Laurie Hook brings experience from previous roles at Relievant Medsystems, Inc., Vibrynt, Inc., Hologic, Inc. and Cardica, Inc.. Laurie Hook holds a B.A. in Biology @ University of California, Santa Cruz. With a robust skill set that includes FDA, Clinical Trials, Medical Devices, Biomedical Engineering, Senior Executive Leadership and more. Laurie Hook has 2 emails and 1 mobile phone numbers on RocketReach.
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