Tanya Shalem
VP of Quality Assurance & Regulatory Affairs at Arineta
Based in Sunnyvale, United States
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Seniority
Vp
Department
Other
Location
Sunnyvale
Industry
Medical Equipment Manufacturing
Company size
87
Contact information
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t•••••••@arineta.com
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Background
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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