Melinda Smith
Director of Regulatory Affairs and Quality - Americas @Elekta
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WORK HISTORY
Director of Regulatory Affairs and Quality - Americas @Elekta
Atlanta, GA, US
Responsible for the strategic and tactical management of Regulatory Affairs and Quality for North, Central and South America.
EDUCATION
The University of Georgia
Master's Degree, Biomedical Regulatory Affairs
Auburn University
Bachelor of Science (BS), Microbiology
The University of Georgia
Certification, Clinical Trials Design and Management
The University of Georgia
Certification, Regulatory Affairs
Georgia State University
Non degreed, Molecular Genetics
ABOUT MELINDA SMITH
QMS regulations including: ISO 13485:2016, 21 CFR 800s, 21CFR210/211, CMDR, PAL Ordinance No. 169, RDC 59 (Brazil) • European Regulation (EU) 2017/745; European Directives and guideline knowledge includes: 93/42/EEC (MDD), 89/686/EEC (PPED), 98/79/EC (IVDD), 65/65/EEC1 and 2001/83/EEC (MPD), 90/385/EEC (AIMDD), MEDDEV, NB-MED, NBOG • Management of external audits including, FDA, Notified Body, MDSAP, Registrar, Internal, Supplier and NIOSH • ISO/EN standards compliance management including working knowledge of horizontal standards such as ISO10993, ISO14971 and ISO 11607. • Validation experience includes: design, test method, process, equipment, sterilization and software • Regulatory submissions include 510(K), 513(g), De Novo, MDEL/MDALL, CE Marking, CSDT, eCDT, STED, and ARTG Listing/WAND • Knowledge of statistical sampling plans and business systems, such as: ANSI/ASQC Z1, MIL Standards, Zero Acceptance Number Sampling Plans, Six Sigma, and LEAN Manufacturing. • Lab management experience includes, but is not limited to: release of raw materials, WIPs, and final product; EMs, bioburden, and sterility; tracking and trending. • General laboratory techniques include: FPLC, HPLC, ELISA, Western Blots, Agarose Gels, PCR, RT-PCR, DNA Cycle Sequencing, DNA Bi-directional Sequencing, tissue culture • Strengths include excellent time management, project management, organization, leadership, and problem solving skills. Highly motivated, self-starter, with team player abilities.
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