Tanya Shalem
VP of Quality Assurance & Regulatory Affairs @Arineta
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WORK HISTORY
VP of Quality Assurance & Regulatory Affairs @Arineta
Business & Industrial Park Caesarea, IL
EDUCATION
Technion - Israel Institute of Technology
ME
Technion - Israel Institute of Technology
B. Sc.
ABOUT TANYA SHALEM
Results-driven quality and regulatory executive with 18 years of progressive experience in the medical device sector, including over a decade in senior leadership roles. Proven track record in securing global regulatory approvals, navigating complex compliance landscapes, and aligning quality and business strategies to support innovation and market expansion. Expert in leading global audits (MDSAP, ISO 13485, FDA, MDR), building scalable QMS frameworks, and mentoring cross-functional teams. Strategic thinker with expertise in cardiovascular and imaging technologies, passionate about driving patient safety, regulatory excellence, and business growth.
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