Yael Buchnik
About Yael Buchnik
Yael Buchnik is a System Engineer with extensive experience in regulatory affairs and project management in the biomedical field. She has worked for several companies, including Venus Concept and Syneron Candela, and currently holds positions at Biosense Webster, where she specializes in quality and regulatory affairs.
Work at BioSense Webster
Yael Buchnik has been employed at BioSense Webster since 2020, serving as a System Engineer. In this role, she is responsible for leading projects through various stages, including design, development, verification, and validation. Additionally, she has been working as a Quality and Regulatory Affairs Specialist since 2019, focusing on ensuring compliance with regulatory standards. Her dual roles at BioSense Webster highlight her expertise in both engineering and regulatory affairs within the biomedical sector.
Previous Experience in Regulatory Affairs
Prior to her current position, Yael Buchnik worked at Venus Concept as a Regulatory Affairs Manager from 2017 to 2019. During her tenure, she was involved in managing regulatory submissions and compliance processes. This experience provided her with a solid foundation in navigating the complexities of regulatory requirements in the medical device industry.
Background in Clinical Feasibility and Product Management
Yael Buchnik has a diverse background in the biomedical field, having worked at Syneron Candela as a Clinical Feasibility Manager from 2012 to 2015 and as a Product Manager from 2011 to 2012. In these roles, she contributed to clinical research and product development, enhancing her skills in data analysis and project management. Her experience in these positions has equipped her with a comprehensive understanding of both clinical and market needs in medical product development.
Education and Expertise
Yael Buchnik earned her Bachelor of Science degree in Biomedical Engineering from the Technion - Israel Institute of Technology, completing her studies from 2005 to 2009. Her educational background provides her with a strong technical foundation, which she applies in her current roles. She possesses expertise in leading projects through the entire product lifecycle, from design and development to verification and validation.
Skills in Regulatory Compliance and Clinical Research
Yael Buchnik has demonstrated proficiency in handling FDA and CE submissions, showcasing her understanding of regulatory requirements in the biomedical field. Her skills extend to clinical research and data analysis, which are critical for the successful development of medical products. This combination of regulatory knowledge and research expertise positions her as a valuable asset in the biomedical industry.