Regulatory Specialist

Overview

Location: Fresno, CA

Salary: $35.00 USD Hourly - $42.00 USD Hourly

Judge Direct Placement is working with a manufacturer in the Fresno area seeking an experienced Regulatory Specialist who is responsible for the development, review, and implementation of compliant product labeling and packaging materials.

• Labeling Compliance:
  Own the process for creating, revising, and approving all labeling components to ensure strict adherence to global and local regulatory requirements.
• Change Control:
  Manage the labeling change control system, coordinating updates across cross-functional teams (Regulatory Affairs, Quality, Manufacturing) to maintain compliance and accuracy.
• Regulatory Monitoring:
  Monitor new and evolving regulations; conduct gap assessments to proactively implement necessary labeling changes.
• Documentation:
  Maintain comprehensive and auditable records of all labeling specifications, history, and approvals within the electronic document management system (EDMS).

• Bachelor’s degree in a scientific or technical field is preferred. Additional experience in lieu of a degree will be considered.
• 5+ years of experience in Regulatory Labeling or Regulatory Affairs within food or beverage manufacturing.
• Expert Knowledge:
  Demonstrated understanding of regulatory requirements (e.g., FDA 21 CFR, EU MDR/IVDR) specific to labeling content and format.
• Skills:
  
  Exceptional attention to detail, advanced proofreading capabilities, and proficiency with EDMS/labeling software.
• Competency:
  
  Proven ability to manage multiple simultaneous projects and collaborate effectively across functional teams.

Contact: