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Regulatory Affairs Specialist II

Katalyst Healthcares & Life Sciences • Seattle, WA, US • published 2026-09-29 02:55:16.067809

Description

**Responsibilities:** * This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysis, problem solving, and attention to detail. * Represent RA on project teams by providing regulatory guidance throughout the product development cycle, coordinate team inputs for regulatory submissions, and review and approve applicable design control documentation. * Support International Product Registrations, including new registrations, re\-registrations, and product change registrations/notifications. * Coordinate and collect specific registration information with R\&D, Quality, Medical, Manufacturing, etc. * Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal "Non\-Filing Justifications (U.S.) for changes that do not require a 510(k) submission. * Prepare/update technical files for...

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