Valeria Bocharova
About Valeria Bocharova
Valeria Bocharova is a Research Associate at C2i Genomics in Haifa, Israel, specializing in regulatory submissions and clinical evaluations for medical devices. She holds advanced degrees in Molecular Biology and Genetics and has extensive experience in research and compliance within the medical field.
Work at C2i Genomics
Valeria Bocharova has been employed as a Research Associate at C2i Genomics since 2021. In this role, she contributes to various research initiatives and projects within the organization, leveraging her expertise in molecular biology and genetics. Her responsibilities include conducting clinical and analytical performance evaluations for In Vitro Diagnostics (IVD) and Software as a Medical Device (SaMD). Additionally, she engages in post-market surveillance for In Vitro Medical Devices (IVMD) to ensure compliance and performance.
Education and Expertise
Valeria Bocharova has an extensive educational background in molecular biology and genetics. She earned her Bachelor of Science (BS) degree from Odessa Mechnikov National University, Ukraine, from 2000 to 2004. She continued her studies at the same institution, achieving a Doctor of Philosophy (PhD) from 2005 to 2011. She also completed a Master of Science (MS) in Molecular Biology and Genetics at Odessa Mechnikov National University from 2004 to 2005. Additionally, she pursued a Post-Doctoral Fellowship at the University of Haifa, Israel, from 2012 to 2016, specializing in plant molecular biology and genetics.
Background
Prior to her current position, Valeria Bocharova worked at the University of Haifa as a Postdoctoral Researcher from 2012 to 2016. She also served as a Research Assistant at CNOGA Medical Ltd. in Caesarea, Israel, from 2019 to 2020. Her experience encompasses a range of roles in research and development, particularly in the field of medical devices and diagnostics.
Regulatory Submissions and Compliance
Valeria Bocharova specializes in regulatory submissions for both FDA and CE-mark, including De novo and BDD processes. She is involved in EUDAMED registration and compliance for medical devices, ensuring that products meet necessary regulatory standards. Her expertise extends to writing clinical study protocols in accordance with ISO 20916 standards and supporting the preparation and maintenance of scientific papers and grant documentation.
Clinical Evaluations and Surveillance
In her professional capacity, Valeria Bocharova conducts clinical and analytical performance evaluations for In Vitro Diagnostics (IVD) and Software as a Medical Device (SaMD). She also engages in post-market surveillance for In Vitro Medical Devices (IVMD), focusing on ongoing compliance and performance. These activities are critical to maintaining the safety and efficacy of medical devices in the market.