Keith Kelly
Senior Regulatory Affairs Manager @Werfen North America
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WORK HISTORY
Senior Regulatory Affairs Manager @Werfen North America
US
EDUCATION
Colorado Technical University
BA, Business Administration / Management
SKILLS
ABOUT KEITH KELLY
Accomplished Post Market Surveillance Manager with more than 10 years of progressive experience and a proven record of significant successful contribution in quality management, project management, process improvements, analysis, and evaluation of quality systems, processes and standards. Exceptionally versatile and detail-oriented with superior organizational, development, problem-solving and communication skills and a strong ability to prioritize and complete multiple tasks simultaneously while quickly adjusting to changes in project requirements and meeting deadlines under pressure. Comprehensive understanding of regulatory obligations for compliance as well as drug and device safety regulations and requirements.Some of my accomplishments include:The introduction and implementation of a Global Quality Complaint Process and Complaint Management team. 100% reduction of late MDRs through the development of processes and training for the team.Streamlining of processes that resulted in the reduction of complaint aging from >365 days to <=60 days. Development of new processes for Technical Support and Quality Team harmonization.Implementation of a robust coding system to easily identify trends and potential root cause resulting in improved metrics.
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