Documentation Specialist

Responsibilities:

  • Manage Label requirements and definition:
    • Integrate the Label Requirements from all the other related disciplines (R&D, Clinical R&D, Marketing, Clinical team, Operation, Regulatory affairs, legal, etc.)
    • Handle translations as applicable
    • Define UDI requirements and implementation
    • Collect inputs throughout product lifecycle
  • Run the Graphics/Drawing process until completion
  • Conduct Label’s V&V as applicable
  • Conduct related ECO’s
  • Integrate and maintain Labels in ERP (BOM)
  • Develop and maintain related work instructions, Incoming Inspection, Labels updates and maintenance
  • Manage translations of Instructions for Use - Optional

Skills and Experience:

  • Familiar with Medical Device Standards and Regulations
  • Labels handling experience of at least 3 years
  • Medical Regulatory Affair Background - Advantage
  • Bio Medical Education – Advantage
  • Instruction for Use Translations Experience- Advantage

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