Regulatory Specialist

Judge Direct Placement is working with a manufacturer in the Cincinnati / Covington area seeking an experienced Regulatory Specialist that is responsible for the development, review, and implementation of compliant product labeling and packaging materials. Key Responsibilities 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). Qualifications 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. #JDP

Created: 2026-03-04