Laura Carpenter
Regulatory Affairs Specialist @Teleflex
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WORK HISTORY
Regulatory Affairs Specialist @Teleflex
Morrisville, NC, US
Principal Responsibilities: •Review and assess change control activities for potential impact on current regulatory filings. •Ensure compliance with design controls. Review design documentation to follow regulatory requirements and provide regulatory expertise and oversight to design teams. •Interpret existing regulations and guidance documents within regulatory department and on project teams. •Interface as needed with FDA, EU Notified Bodies, and Health Canada regarding new products and significant changes to products. •Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of responses to regulatory agency questions and/or requests for information. •Review and approve all Labeling (product, advertising and promotional) verbiage and evaluate for any regulatory impact.
EDUCATION
The University of North Carolina at Chapel Hill
Bachelor of Arts (BA), Public Policy and Communication Studies
SKILLS
ABOUT LAURA CARPENTER
Regulatory Affairs Specialist - Medical Devices
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