Jasmine Levy
Regulatory Affairs Specialist at Tecan
Based in United States
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Seniority
Staff
Department
Science
Location
United States
Industry
Biotechnology Research
Company size
2.4K
Contact information
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j•••••••@tecan.com
Phone
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Background
About Jasmine Levy
Principal Regulatory Consultant with over 20 years of experience in regulatory affairs, quality management, and scientific analysis. Known for guiding complex FDA submissions (510(k), De Novo) and spearheading global compliance initiatives (IVDR, ISO 13485). Expertise spans risk assessments, clinical/non-clinical testing, regulatory pathways, and lifecycle management for Class medical devices. A proven leader in cross-functional collaboration, mentoring teams, and delivering innovative solutions to regulatory challenges. Background in molecular biology, as well as analytical and organic chemistry, strengthens proficiency in device evaluation, biocompatibility, and regulatory compliance.
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