Regulatory Affairs Specialist; Labeling

Regulatory Affairs Specialist (Labeling)

Contract through May 2026 – NO C2C, W2 ONLY. A leading medical device team is seeking a Regulatory Affairs Specialist to support global and EU labeling compliance across a wide range of projects.

• Own regulatory labeling deliverables for new product development, sustaining projects, submissions, and manufacturing transfers
• Ensure compliance with EU MDR, 21 CFR 801, ISO 15223, ISO 20417, and global labeling standards
• Manage and route labeling change control activities
• Create, review, and maintain IFUs, product labels, patient labeling, carton labels, and other artwork
• Collaborate cross-functionally with RA, R&D, Quality, Clinical, Legal, Operations, and Marketing
• Track project schedules, identify risks, and communicate updates
• Support UDI and barcode grading processes

• MS in Science, Engineering, or Regulatory
• 5–9 years of labeling and compliance experience
• Experience in medical device regulatory environments

If you're detail-oriented, collaborative, and experienced with global labeling standards, this is an excellent opportunity to support innovative medical device work.

📩 Interested or know someone who would be a great fit? Message me for details!