Tanya Shalem

VP Of Quality Assurance And Regulatory Affairs at Arineta Cardio Imaging

Tanya Shalem's work experience includes holding various roles at Arineta Ltd. and Biosense Webster. At Arineta Ltd., they started as the Director of QA&RA and was responsible for managing quality and regulatory aspects throughout the product life cycle. Tanya also defined and managed strategic quality objectives and ensured compliance with international standards and regulations. Currently, they hold the position of VP of Quality Assurance & Regulatory Affairs at Arineta Ltd. In this role, they oversee quality assurance and regulatory affairs for the company.

At Biosense Webster, Tanya started as a Quality & Regulatory Specialist and provided support for new product development projects. Tanya also managed regulatory registrations and submissions in multiple countries. Subsequently, they assumed roles as Manager of Quality Systems and Compliance, Manager of Medical Device Regulatory Compliance, and Manager of Quality Systems. In these roles, they maintained comprehensive quality management systems, managed regulatory compliance, hosted health authority audits, and led internal audit programs.

Overall, Tanya Shalem has a strong background in quality assurance, regulatory affairs, and compliance management in the medical device industry.

Tanya Shalem earned a B. Sc. degree in Bio-Processes Quality Engineering from Technion - Israel Institute of Technology, which they attended from 2002 to 2006. Tanya later pursued an ME degree in Industrial Engineering and Management from the same institution from 2007 to 2010.

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Timeline

  • VP Of Quality Assurance And Regulatory Affairs

    March, 2022 - present