Global Business Unit Labeling Specialist

Irvine, CA

Post Date: 06/08/2018 Job ID: JN -062018-25447 Industry: Manufacturing & Engineering
We are currently seeking a Global Business Unit Labeling Specialist to be the subject matter expert (SME) that collaborates with Business Unit customers and cross-functional stakeholders (Regulatory, Packaging, Quality, Marketing, NPD etc.) to deliver successful labeling changes and requested new labeling. The Global Business Labeling Specialist will be responsible for consolidating labeling requirements and scope, and timelines for labeling changes required for new product project teams and for other sustaining business needs.

Global Business Unit Labeling Specialist Responsibilities:
  • Drive labeling activities to initiate and deliver to Operations labeling content changes through updates to product labels, instructions for use (IFU) and other forms of regulated labeling materials, in compliance with global and regional standards and regulations.
  • Responsible for engaging cross-functional teams to resolve obstacles, meet key labeling objectives, and collaborate on continuous improvement initiatives.
  • Support development of solutions for labeling initiatives
Global Business Unit Labeling Specialist Key Requirements:
  • Science-related Bachelors Degree, Project Management Professional desired
  • Minimum of 3 years labeling experience in either Medical Device Industry or Pharmaceutical
  • Excellent interpersonal and communication skills
  • Experience developing labeling for medical devices for FDA and global markets preferred
  • Experience developing or improving documentation (i.E. SOPS) in an FDA regulated industry preferred
Compensation & Benefits:
  • Salary between $65k-75k annually
  • Comprehensive Benefits package
  • Possible Relocation benefits for the right candidate

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