Paula Morgan
Vice President: Quality and Regulatory Affairs: Hemostasis and Acute Care Diagnostics Business Unit at Werfen North America | San Diego, California, United States
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Paula Morgan serves as the Vice President of Quality and Regulatory Affairs for the Whole Blood Hemostasis Business Unit at Werfen North America, where she leverages her extensive 25 years of experience in the medical device industry to drive compliance and quality excellence. In her current role, Paula is instrumental in leading the Quality and Regulatory functions, ensuring that all products meet stringent domestic and international regulations governing in vitro diagnostic and sterile Class II medical devices. Her expertise in regulatory strategy and ISO 13485 standards allows her to effectively navigate the complexities of regulatory submissions, ensuring that Werfen’s innovative solutions align with U.S. Food and Drug Administration (FDA) requirements and international regulations.
Paula is recognized as a change agent within the organization, adept at translating global regulatory requirements into actionable strategies that support business objectives. She plays a pivotal role in the development and implementation of robust quality systems, which are essential for maintaining compliance and enhancing product quality. As the Management Representative and Person Responsible for Regulatory Compliance (PRRC) for the Whole Blood Hemostasis Business Unit, Paula oversees all aspects of Quality Control and Quality Assurance, ensuring that documentation and processes adhere to the highest standards.
Her leadership extends to key projects that focus on integrating Unique Device Identifiers (UDIs) into product lines, enhancing traceability and compliance. Paula's commitment to fostering a culture of quality and regulatory excellence not only drives operational efficiency but also positions Werfen as a trusted leader in the medical device sector. Her ability to build bridges between regulatory frameworks and business needs is a testament to her strategic vision and dedication to advancing patient care through innovative diagnostic solutions.
Vice President: Quality and Regulatory Affairs: Hemostasis and Acute Care Diagnostics Business Unit at Werfen North America in April 2017 to Present
Vice President: Clinical & Regulatory Affairs, and Quality Assurance at NuVasive in September 2015 to January 2017
Sr. Director: Global Regulatory Affairs at NuVasive in January 2010 to January 2015
Sr. Director: Regulatory Affairs & Quality System Compliance at Alphatec Spine in January 2006 to January 2010
Manager: Regulatory Affairs & Quality System Compliance at Zimmer Biomet in January 1998 to January 2006
Research Associate at Vista Biologicals Corporation in January 1995 to January 1998
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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
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Discover more about Werfen North AmericaWhat is Paula Morgan email address?
Email Paula Morgan at [email protected]. This email is the most updated Paula Morgan email found in 2026.
What is Paula Morgan phone number?
Paula Morgan phone number is +17608155124 and +18582632590.
How to contact Paula Morgan?
To contact Paula Morgan send an email to [email protected]. If you want to call Paula Morgan try calling on +17608155124 and +18582632590. (updated on October 30, 2024)
What company does Paula Morgan work for?
Paula Morgan works for Werfen North America
What is Paula Morgan's role at Werfen North America?
Paula Morgan is Vice President: Quality and Regulatory Affairs: Hemostasis and Acute Care Diagnostics Business Unit
What industry does Paula Morgan work in?
Paula Morgan works in the Medical Equipment Manufacturing industry.
Paula Morgan Email Addresses
Paula Morgan Phone Numbers
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