Regulatory Specialist (1114203) jobs in United States
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The Judge Group · 2 days ago

Regulatory Specialist (1114203)

The Judge Group is seeking an experienced Regulatory Specialist responsible for the development, review, and implementation of compliant product labeling and packaging materials. The role involves managing labeling compliance, change control, regulatory monitoring, and documentation to ensure adherence to regulations.

E-LearningInformation TechnologyProfessional Services

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)

Qualification

Regulatory LabelingRegulatory AffairsFDA 21 CFREU MDR/IVDREDMS/labeling softwareAdvanced proofreadingAttention to detailProject managementCollaboration

Required

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

Preferred

Bachelor's degree in a scientific or technical field is preferred. Additional experience in lieu of a degree will be considered

Company

The Judge Group

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Results through the Power of Experience.

Funding

Current Stage
Public Company
Total Funding
unknown
1997-02-14IPO

Leadership Team

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Charlton Monsanto
Executive Vice President of Integrated Services and Innovation
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