Dawn N. Norman

About Dawn N. Norman

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

Experience

1. Partner

   Mrc Global

   Apr 2020 — Present · 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

• Southern Illinois University Edwardsville

  MS, Biomedical Sciences and Chemistry

  1992 — 1995

Skills

• Medical Devices
• Clinical Research
• Capa
• Ind
• Iso 13485
• Class Iii
• Ce Marking
• Class I
• Class Ii
• U.s. Food and Drug Administration (Fda)
• Compliance
• Sop
• Fda
• Quality System
• Regulatory Affairs
• Lifesciences
• Protocol
• Design Control
• Biologics
• Validation
• 510k
• Clinical Trials
• Life Sciences
• Regulatory Submissions
• Biomedical Engineering
• Gmp
• 21 Cfr Part 11
• Iso 14971
• Quality Assurance
• Pma
• Change Control
• Clinical Development