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Regulatory Affairs Specialist III

Katalyst Healthcares & Life Sciences • Chicago, IL, US • published 2026-09-29 02:55:16.067742

Description

**Responsibilities:** * The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and de novo devices) * The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards * Develop regulatory strategies to achieve market clearance in an effective and efficient manner * Prepare, submit, and maintain product registrations, certifications, and approvals to meet US, EU and other regulatory requirements as applicable: * 510(k) and/or De Novo submissions for FDA * Technical documentation for EU MDR compliance * International product registration activities to meet business objectives * Provide regulatory input to support product labeling * Monitor new and changing regulatory requirements and ensure the business understands relevant impacts * Lead corrective and preventive action (CAPA) efforts as assigned * Product Development Support: * Provide regulatory input through...

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