Regulatory Affairs Specialist

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.

• 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 authorities, such as FDA and TÜV
• Bachelor's degree in a relevant scientific discipline or equivalent experience in Regulatory Affairs, Life Sciences, Biology, Biomedical Engineering.
• 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