Regulatory Affairs Specialist

Katalyst Healthcares & Life Sciences • Avenel, NJ, US • published 2026-09-23 05:43:16.120403

Description

**Role Summary:** Responsible for global coordination and preparation of regulatory submission documents/packages for Baxter medical devices. The role involves reviewing technical/scientific data, supporting regulatory strategies, preparing responses to regulatory authorities, and ensuring regulatory documentation meets applicable requirements across the U.S. and international markets, especially EU regulations. **Key Responsibilities:** * Support execution of regulatory project plans. * Compile and prepare global regulatory submissions. * Review technical and scientific data supporting submissions. * Prepare responses to questions from regulatory authorities. * Maintain regulatory files and documentation. * Assist with labeling, SOPs, and departmental documents. * Track regulatory submission/documentation status. * Edit and proofread regulatory documents. * Participate in cross\-functional project teams. * Manage multiple regulatory projects and priorities. **Must\-Haves:** * Experience with medical devices / healthcare regulatory affairs. * Knowledge of U.S. and OUS device regulations, especially EU regulations. * Experience developing or supporting Regulatory Affairs strategies....

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