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Abbott Laboratories

Senior Quality & Regulatory Specialist

alameda, CA

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Job description

Abbott Laboratories in Alameda, CA is seeking a Sr. Quality Specialist to lead complex quality and regulatory initiatives that impact patient safety and business operations.

You will own complaint assessments, regulatory reporting decisions, and submissions such as MDRs, MedWatch, and Vigilance, partnering with cross-functional teams to drive improvements. The role requires strong knowledge of ISO 13485, FDA QSR, and 21 CFR Part 11, plus experience in supplier quality and CAPA processes.

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Worksite address

alameda, CA, 94501, US

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