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Edwards Lifesciences logo

Senior Representative, Labeling

Edwards Lifesciences · Kuala Lumpur BSC, Malaysia

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RegulatoryFull-timeCompany career page

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Role summary

This senior labeling role manages complex label change packages across business units for Edwards Lifesciences' cardiovascular product supply chain. The position involves executing regulatory documentation, process improvements, and team training while maintaining compliance with Good Documentation Practices. Requires an associate's degree plus four years of related experience, or high school diploma plus six years in labeling operations.

What they're looking for

  • Associate's degree or equivalent with 4 years related experience, or high school diploma with 6 years related experience
  • Proficiency with MS Office Suite and labeling systems applications
  • Strong written and verbal communication with attention to detail
  • Knowledge of labeling requirements and Good Documentation Practices across business units
  • Ability to read, comprehend, and write English fluently
  • Experience working in team environments under general supervision

What you'll be doing

  • Execute label change packages including ECO updates, mass changes, and ECR generation with limited direction
  • Document change intent accurately within quality systems adhering to GDP standards
  • Follow up on change requests and manage approvals for timely closure
  • Evaluate routine risks and recommend solutions to resolve issues
  • Train and coach team members on labeling processes and improvements

Privacy & handoff

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What RoleLantern checked

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RoleLantern checked active
RoleLantern checkedNeeds clarity
Date posted45 days ago
Last source check1 day ago
Salary listedNeeds clarity
Location clearClear
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