Documentation Specialist

Haifa        ·       Full time

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

Advantages:

• 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

Please click here to apply.