
Documentation Specialist
1 week ago
Job Title: Documentation Specialist
Develop and maintain clear, accurate, and compliant documentation for medical products.
Key Responsibilities:- Create high-quality technical content (IFU, DFU, labels, manuals, quick-start guides, digital aids).
- Translate complex scientific/regulatory information into clear, user-centric documentation.
- Ensure compliance with regulatory requirements, including IVDD/IVDR, FDA 21 CFR Part 11, ISO 13485, and internal quality standards.
- Collaborate with cross-functional teams.
- Contribute to continuous improvement of documentation standards and processes.
Requirements:
- Experience in technical writing for life sciences/medical devices.
- Strong knowledge of regulatory documentation requirements.
- Excellent writing, editing, and collaboration skills.
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