Documentation Specialist

What you will be doing:

  • Manage Label requirements and definition:
    • Integrate the Label Requirements from all the other related disciplines (R&D, Clinical R&D, Marketing, Operation, Regulatory affairs, QA, etc.)
    • Handle translations as applicable
    • 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 / product tree)
  • Develop and maintain related work instructions, Incoming Inspection, Labels updates and maintenance
  • Manage translations of Instructions for Use - Optional

What you have:

  • Good English
  • Highly motivated, team player


  • Familiar with Medical Device Standards and Regulations
  • Labels handling experience of at least 3 years
  • Medical Regulatory Affair Background
  • Bio Medical Education
  • Instruction for Use Translations Experience
  • Graphic design
  • Being introduced by an Insightec employee


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