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Paula Morgan Location
San Diego, CA, US
Paula Morgan Work
Vice President: Quality and Regulatory Affairs: Whole Blood Hemostasis Business Unit @ (April 2017 - Present)
Vice President: Quality and Regulatory Affairs: Point of Care Hemostasis @ (April 2017 - Present)
Vice President: Clinical and Regulatory Affairs, and Quality Assurance @ (September 2015 - January 2017)
Sr. Director: Global Regulatory Affairs @ (January 2010 - January 2015)
Sr. Director: Regulatory Affairs and Quality System Compliance @ (January 2006 - January 2010)
Manager: Regulatory Affairs and Quality System Compliance @ (January 1998 - January 2006)
Paula Morgan Education
University of New Hampshire
B.S (Microbiology)
Paula Morgan Skills
External Audits
standards
Common Sense
Global Regulatory Compliance
Regulatory Strategy
Regulatory Compliance
Quality Management
Quality System Compliance
Medical Devices
ISO 13485
Quality System
Regulatory Affairs
ISO 14971
Design Control
Regulatory Submissions
Product Development
CAPA
Product Launch
CE marking
Biotechnology
U.S. Food and Drug Administration (FDA)
Spine
Orthopedics
Manufacturing
V&V
Biologics
Medical Device Directive
Corrective and Preventive Action (CAPA)
ISO Standards
Verification and Validation (V&V)
Training
International Regulations
Advertising & Promotion
Device Labeling
Unique Device Identifiers
EU Medical Device Directive
AATB
HCT/P compliance
FDA Inspections
ISO Audits
FDA
PMA
Business Development
Research
Process Improvement
Licensing
u.s. Food and Drug Administration Fda
Sales
Social Media Marketing
Content Curation
ISO
Verification and Validation V&V
Content Discovery
Inbound Marketing
Project Management
Corrective and Preventive Action Capa
International
Advertising and Promotion
Orthopedic
Trackwise
Sop
Pharmaceutics
u.s. Food and Drug Administration
Corrective and Preventive Action
Verification and Validation
Paula Morgan Summary
Paula Morgan, based in San Diego, CA, US, is currently a Vice President: Quality and Regulatory Affairs: Whole Blood Hemostasis Business Unit at Werfen North America. Paula Morgan brings experience from previous roles at Werfen North America, NuVasive and Alphatec Spine. Paula Morgan holds a B.S in Microbiology @ University of New Hampshire. With a robust skill set that includes External Audits, standards, Common Sense, Global Regulatory Compliance, Regulatory Strategy and more. Paula Morgan has 1 emails and 4 mobile phone numbers on RocketReach.
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