Lori Kegel

Sr Manager Labeling Technology and Operations @St. Jude Medical

Minneapolis, MN, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jul 2012 — Present

Sr Manager Labeling Technology and Operations @St. Jude Medical

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Minneapolis, MN, US

Sr. Manager, Labeling Technology and Operations (present)Establish strategic direction for labeling technology operations and UDI compliance for multiple product divisions. Lead a team of professional Managers, Analysts, Specialists, and Project Managers responsible for executing functional processes necessary to support the creation of globally released product labeling in fulfillment of existing and emerging medical device regulations. Adhere to design controls and quality system procedures. Meet FDA, QSR, ISO, and other international standards and mandates. Fulfill all deadline and budget management planning and constraints. Cement team cohesiveness through consistent recognition and mentoring as the decisive leader of cross-functional groups.

EDUCATION

1980 — 1985

University of Wisconsin-Stevens Point

Bachelors Degree, Communication

SKILLS

Regulatory Affairs (Raps Certificate - Medical Device)21 Cfr Part 11Change ControlFramemakerTechnical CommunicationDmaicRegulatory SubmissionsContinuous ImprovementLeadershipQuality AssuranceChange ManagementProcess ImprovementFmeaDesign ControlSoftware DocumentationRoot Cause AnalysisTeam BuildingManagementCapital EquipmentRegulatory RequirementsRegulatory AffairsSix SigmaProduct LaunchQuality AuditingR&DIso 13485Market DevelopmentIsoTechnical WritingClinical TrialsFdaBiomedical EngineeringSpcProject ManagementCommercializationMedical DevicesCapaProduct DevelopmentQuality SystemV&V

ABOUT LORI KEGEL

Highly creative, excellence-driven Labeling manager with 15+ years of advanced leadership experience used to optimize and meet all quality assurance and control requirements for product labels and literature content for medical devices. Innovator transforming internal productivity and capital outlay through effective management and process improvements. • Fully complaint with corporate and global regulatory mandates. • Cross-functional leader leading top-functioning teams in the execution of multi-million-dollar projects, consistently meeting deadline and budget requirements.

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Lori Kegel — Sr Manager Labeling Technology and Operations at St. Jude Medical in Minneapolis, MN, US | Unifers