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. Experience working with cross-functional teams. Experience interacting with external regulatory authorities, such as FDA and TÜV. Bachelor's degree in a relevant scientific discipline or equivalent experience.
