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. What You’ll Do: 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 What We’re Looking For: 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! #J-18808-Ljbffr