Regulatory Affairs Specialist II

Katalyst HealthCares & Life Sciences

Full-time Seattle, Washington Business Operations Specialists

Posted:

June 19, 2026

Location:

Seattle, Washington, United States

Job Description

 Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the 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, Man...

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Job Overview

Job Type: Full-time

Location: Seattle, United States

Posted: June 19, 2026

Deadline: July 29, 2026