SEKISUI Diagnostics
Marian Gerdes has extensive experience in quality and regulatory affairs, with a career spanning several prominent companies in the healthcare and diagnostics sectors. Currently seeking new opportunities, Marian served as a Quality & Regulatory Manager at Open to New Opportunities, and held senior roles at Sekisui Diagnostics, LLC, and Thermo Fisher Scientific, where responsibilities included regulatory compliance and the establishment of systems for labeling and promotional materials. Prior experience includes positions at Allergan and Baxter Healthcare, focusing on pharmacovigilance and safety systems management, and a lengthy tenure at Abbott Laboratories in various roles related to medical event reporting and quality assurance. Marian holds a Bachelor of Science in Medical Technology from Western Illinois University.
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SEKISUI Diagnostics
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Headquartered in Burlington, MA, for 40 years SEKISUI Diagnostics has been committed to helping improve the lives of patients by providing innovative medical diagnostics to physicians and laboratories. We continue to invest in the areas of diabetes, infectious disease, coagulation, diagnostic enzymes and automated systems, and have a leading position as a provider of rapid tests in the US and high throughput coagulation systems in Japan. Our workforce spans six sites located in four countries. We are a sister company to SEKISUI Medical in Japan, making us a worldwide company with R&D and Manufacturing facilities on three continents. We develop, manufacture, and supply billions of tests each year to the global healthcare market through our commercial networks and partners. Our product lines include: • Clinical chemistry reagents • Coagulation reagents • Point-of-care rapid tests and immunoassay system • Enzymes and specialty biochemicals