Required skills
- Instructions for Use (IFU) Strategy
- Content Management
- Structured Authoring
- Technical Documentation
- Regulatory Requirements (MDR, FDA)
- AI-assisted Content Creation
- Content Reuse
- Traceability
- Revision-proof Documentation
- Process Development
- Documentation Structure
Languages: German
Job description
Develop a modern concept for the creation and maintenance of instructions for use (IFUs) that meets regulatory requirements and maximizes efficiency in creation, review, and maintenance.
Project overview
Together with our specialist departments, you will develop a modern concept for the creation and maintenance of instructions for use that meets regulatory requirements and at the same time enables maximum efficiency in creation, review, and maintenance.
The goal is not to manually create classic documents, but to build a methodologically sound and traceable structure that consistently uses current technical possibilities, for example:
You have proven experience in:
Experience with defibrillators or comparable products is not a must. Experience with medical devices of higher risk classes is helpful, but secondary for us.
What is crucial is your methodological strength: You understand how documentation can be structured to remain scalable, maintainable, and regulatorily traceable.
Do you recognize yourself in this profile and are you eager to shape the IFU landscape of the future with us? Then contact us at *@*.com and send us your CV, your availability, and your hourly rate. We look forward to hearing from you!
Job facts: Direct client project
- AI-supported content creation and content reuse
- Content management systems and modular documentation
- Traceability between requirements, product features, and documentation
- Automated or semi-automated derivation of different IFU variants
- Efficient review and change processes
- Remediation and new creation of extensive IFUs or technical documentation
- Building processes and documentation structures in a regulated environment
- MDR, FDA, and comparable regulatory requirements
- Content management, structured authoring, or similar approaches
- Traceability concepts and revision-proof documentation
- Use of modern technologies and AI tools for document creation
Project details
- Start: ab sofort
- Remote: hybrid
- Location: Kaufering, Deutschland, DE
- Languages: German
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