Dawn N. Norman

Partner @Mrc Global

Memphis, TN, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Apr 2020 — Present

Partner @Mrc Global

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Memphis, TN, US

MRC Global (formerly MRC|X) offers a comprehensive solution for your regulatory, quality or clinical consulting needs with a focus on life sciences, including medical devices, biologics and tissues. We are proud to offer tailored services to meet your project completion or strategic guidance objectives, regardless of company size or budget. In addition, we also offer access to transactional and physician leadership / Key Opinion Leader (KOL) advisory services and provide assistance with Sunshine Act reporting.Services include, but are not limited to, regulatory assessment and strategy, 510(k), EUA, IDE, PMA, HDE, technical files and design dossiers for CE Marking, Quality System implementation, remediation or maintenance, DHF remediation, quality system audit preparation, internal and supplier audits, regulatory and quality systems training, MDRs, change control, labeling, clinical protocol development, etc

EDUCATION

1992 — 1995

Southern Illinois University Edwardsville

MS, Biomedical Sciences and Chemistry

SKILLS

Medical DevicesClinical ResearchCapaIndIso 13485Class IiiCe MarkingClass IClass IiU.s. Food and Drug Administration (Fda)ComplianceSopFdaQuality SystemRegulatory AffairsLifesciencesProtocolDesign ControlBiologicsValidation510kClinical TrialsLife SciencesRegulatory SubmissionsBiomedical EngineeringGmp21 Cfr Part 11Iso 14971Quality AssurancePmaChange ControlClinical Development

ABOUT DAWN N. NORMAN

Experienced executive with a demonstrated history of working in the medical device…

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