Paula J. Morgan
Vice President Quality and Regulatory Affairs @Werfen North America
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WORK HISTORY
Vice President Quality and Regulatory Affairs @Werfen North America
Overall Quality and Regulatory responsibility for Werfen Whole Blood Hemostasis Business Unit in San Diego to ensure compliance with state, federal, international regulations governing in vitro diagnostic and sterile Class II medical devices. Acts as Management Representative/PRRC for this business unit Responsible for all Quality Control, Quality Systems Compliance, Quality Assurance, Document Control, Quality Engineering, and Regulatory Affairs teams in order to provide regulatory and quality expertise and support for products and business objectives globally. Provide objective evaluation of quality performance, regulatory issues, and guidance for implementation of corrective and preventive actions. Provide regulatory guidance regarding product development, labeling and advertising material, change control, risk analysis, design verification and validation to ensure ongoing compliance with regulatory requirements. Oversee preparation and maintenance of both U.S. and foreign regulatory submissions and other premarket filings and registrations to acquire appropriate commercial distribution clearances in an expeditious manner. Develop of highly effective and efficient regulatory strategies that deliver the fastest time to market for new and modified medical devices globally. Maintain timely establishment registrations, state manufacturing licenses, federal device listings, and other pertinent device licensing. Led external audits with FDA, EU Notified Body, and other regulatory agencies with successful outcomes. Evaluate and implemented process changes to drive compliance to regulatory requirements Updated quality system following self-directed gap assessment in order to obtain MDSAP certification. Oversee Document Control and Quality System teams to ensure compliant and effective processes
EDUCATION
University of New Hampshire
B.S, Microbiology
SKILLS
ABOUT PAULA J. MORGAN
Highly effective, results-oriented professional with 25+ years of increasing…
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