Regulatory Affairs Specialist (Labeling)

Redbock - an NES Fircroft company; Irvine (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading medical device firm located in California is seeking a Regulatory Affairs Specialist to manage global labeling compliance. The role involves owning labeling deliverables for product development, ensuring compliance with various global standards, and managing change control activities. Ideal candidates will have 5–9 years of relevant experience and a Master's degree in a related field. This opportunity promises to be a significant contribution to innovative medical device projects.

Qualifications

• 5–9 years of labeling and compliance experience.
• Experience in medical device regulatory environments.

Responsibilities

• Own regulatory labeling deliverables for new product development.
• Ensure compliance with EU MDR and global labeling standards.
• Manage labeling change control activities.

Skills

Detail-oriented

Collaborative

Regulatory compliance

Labeling standards

Education

MS in Science, Engineering, or Regulatory

Job description

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!