[Hiring] Regulatory Affairs Specialist @Katalyst Healthcares & Life Sciences

Role Description

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
• Ensuring regulatory documentation meets applicable requirements across the U.S. and international markets, especially EU regulations

Qualifications

• 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

Requirements

• 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