Labeling Operations Specialist

Johnson & Johnson Innovative Medicine

Danvers, Massachusetts, United States
Fully remote
Labeling change request processing
Cross-functional team collaboration
Regulatory compliance
Johnson & Johnson is seeking a Labeling Operations Specialist for their Innovative Medicine sector, focusing on managing labeling change requests in compliance with regulatory standards. The role emphasizes collaboration with cross-functional teams to ensure accurate and compliant labeling for medical devices

Job Summary

  • Review and process labeling change requests in accordance with J&J and regulatory standards, supporting cross-functional teams to ensure accuracy and compliance.
  • Support New Product Development and Lifecycle teams in executing labeling strategies, including label and IFU development for new product launches and lifecycle revisions.
  • Employees are eligible for comprehensive benefits including medical, dental, vision, retirement plans, and various paid time off benefits.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Labeling Operations Specialist for their Innovative Medicine sector, focusing on managing labeling change requests in compliance with regulatory standards. The role emphasizes collaboration with cross-functional teams to ensure accurate and compliant labeling for medical devices.

Skills & Requirements

Must-have

  • Labeling change request processing
  • Cross-functional team collaboration
  • Regulatory compliance
  • Change control processes
  • Global regulatory standards

Nice-to-have

  • Streamline change request workflows
  • Project management experience
  • Medical device experience

Key Requirements

  • 4+ years experience supporting labeling or regulatory operations
  • Bachelor's degree in a relevant field
  • Exposure to medical devices
  • Exposure to regulatory compliance
  • Exposure to change control processes
  • Strong written and oral communication skills
  • Knowledge of global regulatory standards (FDA, EU MDR, ISO)

Work Rights

Not specified

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