Regulatory Affairs Specialist

Job Description

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