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Regulatory Affairs Specialist

The Metrix Company • Dubuque, IA, US • published 2026-10-23 02:05:07.174307

Description

The Metrix Company, a leading manufacturer of single\-use medical devices, is seeking a quality\-driven Regulatory Affairs Specialist to join our team. This person will work directly with Engineering and Quality Assurance to maintain the knowledge base of existing and emerging regulations, standards, or guidance documents. The Regulatory Specialist is responsible for maintaining regulatory compliance as new or revisions of standards and product designs are released. This person will also be the technical expert in resolving potential regulatory issues, deficiencies, and questions from regulatory agencies. Other duties include: * Assures regulatory compliance to ISO 13485, FDA 21 CFR 820, and Medical Device Single Audit Program. Lead the audit program to ensure ongoing compliance. Develop and maintain the annual internal audit schedule, plan and conduct risk\-based internal audits, oversee auditor training/qualification, and track timely closure of audit findings. Assists in maintaining the Company’s Quality Management System (QMS) and assists in the review and development of standard operating procedures (SOP’s) which support regulatory compliance to standards, customer requirement...

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