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Janie Mandrusov

Vice President Clinical Affairs @T45 Labs

Santa Clara, CA, US
EMAILS
j••••••••@t45labs.com
MOBILE NUMBERS
+14•••••••74

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WORK HISTORY

Jan 2023 — Present

Vice President Clinical Affairs @T45 Labs

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T45 Labs is a specialized medical technology innovation company located in Santa Clara, Silicon Valley, California. Portfolio of companies include VahatiCor, Advanced NanoTheraopies, NuevoSono, & ReCava.

EDUCATION

N/A

UC San Diego

BS, Biomedical Engineering

N/A

Columbia Engineering

Ph.D., Chemical Engineering

SKILLS

Medical DevicesFdaDesign ControlBiomedical EngineeringR&DClinical TrialsCommercializationCapaClinical DevelopmentProduct DevelopmentBiotechnologyRegulatory SubmissionsValidationRegulatory AffairsIso 14971Drug DeliveryGlpGmpTechnology TransferSopCross-Functional Team LeadershipSurgeryV&VClinical ResearchIso 13485LifesciencesBiomaterialsQuality SystemCRO21 Cfr Part 11Market DevelopmentBiologicsLife SciencesLaboratoryGood Laboratory Practice (Glp)Research and Development (R&D)U.s. Food and Drug Administration (Fda)

ABOUT JANIE MANDRUSOV

Executive leader with over 25 years of experience in the medical device industry developing products in cardiovascular, peripheral vascular, wound care, biologics, orthopedics, ENT, and spine space.• Strategic thinker with the ability to translate business needs into clinical trial strategy and design coupled with strong analytical skills, and a high attention to detail to ensure successful execution of clinical trials. • Expert in development and implementation of regulatory & clinical strategy to bring FDA regulated products to market, including Q-sub process, 510(k), IDE submission, and study execution• Results oriented, highly motivated, creative driver with positive attitude

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