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Immunodiagnostic Documentation Professional
3 weeks ago
We are seeking a skilled Documentation Specialist to develop and maintain clear, accurate, and compliant documentation for immunodiagnostic products.
Key Responsibilities:
- Create and edit high-quality technical content (IFU, DFU, labels, manuals, quick-start guides, digital aids).
- Translate complex scientific/regulatory information into clear, user-centric documentation.
- Evaluate compliance with IVDD/IVDR, FDA 21 CFR Part 11, ISO 13485, and internal quality standards.
- Collaborate with Product Development, Regulatory, QA, Marketing, and Operations teams.
- Contribute to continuous improvement of documentation standards and processes.
Qualifications:
- Experience in technical writing for life sciences/medical devices.
- Strong knowledge of regulatory documentation requirements.
- Excellent writing, editing, and collaboration skills.
Prioritizing excellence in documentation is crucial to our success. If you have a passion for creating high-quality documentation and a keen eye for detail, we encourage you to apply.
