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Regulatory Affairs Specialist

Katalyst Healthcares & Life Sciences • Charlotte, NC, US • published 2026-09-29 02:55:16.068146

Description

**Responsibilities:** * The Regulatory Affairs Specialist is responsible for working with cross\-functional teams to bring IVD (In\-Vitro Diagnostic), Research (RUO) and Laboratorial products to market and support activities related to Quality Management System (QMS) to ensure ongoing compliance while continuing to develop regulatory affairs skills * This position reports to the Director, Quality Assurance and Regulatory Compliance (Management Representative) and is part of the Regulatory Compliance team located in Richmond, Illinois and will be onsite * Support product registrations, listings, and renewals globally with the support of Leica partners, and directly in US, Canada, and EU markets, requiring cross\-functional and cross\-site partnership and execution for new products and change management * Support new product development, design change, and sustainment projects by reviewing and approving design files connected to regulatory compliance, using strong problem solving and decision\-making skills * Prepare, review, and approve regulatory documentation for submission, including but not limited to Technical Files and DoCs to regulatory agencies or to commercial partners, and...

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