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
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
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