All jobs → Partner boards

Regulatory Affairs Specialist

Katalyst Healthcares & Life Sciences • Richmond, IL, US • published 2026-09-29 02:55:16.067876

Description

**Responsibilities:** * This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA and EU regulations, ISO standards, and other regulatory agencies * Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA supplements, pre\-submissions, 510(k)s, annual reports, and MDR CE mark submissions * Develop and implement regulatory strategies for new and modified products * Act as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, commercialization, and coordinating team inputs for submissions * Act as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre\-submission strategy/regulatory pathway development, testing requirements, clarification and follow\-up of submissions under review * Review and approve design and manufacturing changes for existing products, ensuring ...

Get jobs like this daily in Telegram: @careeri_bot