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Quality & Regulatory Affairs Specialist

Eppendorf • Enfield, CT, US • published 2026-10-09 03:03:30.848407

Description

### **How you can make an impact** The Quality \& Regulatory Affairs Specialist will serve as the SME for federal, state, and Canadian product regulations. You will translate changing requirements into clear actions that help our teams remain compliant and support our customers. * As the regional point of contact for Quality Management and Regulatory Affairs, you coordinate requests, escalations, and cross\-functional support for Sales and Service across the Americas region. * You monitor and analyze federal, state, Canadian, and provincial requirements relevant to Eppendorf instruments, products, operations, waste, and gas, using regulatory databases, government websites, and other reliable sources. * Through a regulatory master list and structured gap analyses, you identify new or amended requirements, assess their applicability, and coordinate follow\-up with Corporate Quality, Regulatory Affairs, and R\&D. * You support and continuously improve the Commercial Quality Management System, including document control, change management, nonconformance management, CAPA, risk management, management review, and internal\-audit activities. * For audits and inspections, you prepare evide...

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