Labeling Compliance Specialist

3 days ago

Houston, Texas, United States Intellectt Inc Full time

Hi All,

One of my clients is looking
Role: Labeling Change Control Specialist. If
you're interested or your skills match, please share with me your updated resume to

Position:
Labeling Change Control Specialist

Location:
Irving, TX (Onsite)

About the Role

We are seeking a
Labeling Change Control Specialist
to support and manage labeling updates within a leading medical device organization. The ideal candidate will have hands-on experience with change control processes, cross-functional coordination, and regulatory compliance related to labeling documentation and artwork management.

Key Responsibilities

Labeling Change Management

  • Initiate, track, and manage labeling change controls using electronic Quality Management Systems (eQMS) or document management tools.
  • Coordinate cross-functional reviews with Regulatory Affairs, Quality, Packaging, Manufacturing, Supply Chain, and Marketing.
  • Ensure timely implementation of approved labeling changes to support product launches, regulatory updates, and artwork revisions.

Documentation and Control

  • Maintain labeling master data and version histories for products and packaging components.
  • Prepare and review labeling change documentation, including change request forms, impact assessments, and approvals.
  • Ensure compliance with applicable regulatory requirements and internal standards.

Cross-Functional Collaboration

  • Liaise with global labeling teams, manufacturing sites, and external vendors such as artwork studios and printers.
  • Support internal and external audits by providing accurate labeling records and traceability documentation.

Compliance & Continuous Improvement

  • Ensure labeling processes align with corporate SOPs, FDA, EMA, and other global regulatory guidelines.
  • Identify and implement opportunities to streamline labeling workflows.
  • Support CAPA and deviation investigations related to labeling issues.

Qualifications

  • Bachelor's degree in Life Sciences, Engineering, Quality, or a related field.
  • 3+ years of experience in labeling change management or document control within a regulated industry (medical device or pharmaceutical preferred).
  • Proficiency with eQMS systems and document management tools.
  • Strong understanding of regulatory requirements (FDA, ISO 13485, etc.).
  • Excellent organizational, communication, and cross-functional collaboration skills.

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