
Technical Documentation Specialist
5 days ago
Role Overview:
Our organization seeks a skilled documentation specialist to develop, maintain and deliver high-quality documentation for life sciences products.
Key Responsibilities:- Create user-centric content including IFUs, user manuals, product labels, and digital learning aids.
- Translate complex scientific/regulatory information into clear, accurate, and compliant documentation.
- Ensure compliance with regulatory standards, such as IVDD/IVDR, FDA 21 CFR Part 11, and ISO 13485.
- Collaborate with cross-functional teams, including Product Development, Regulatory, QA, Marketing, and Operations.
- Contribute to continuous improvement of documentation processes and standards.
Required Skills and Qualifications:
- Experience in technical writing for life sciences/medical devices.
- Strong knowledge of regulatory documentation requirements.
- Excellent writing, editing, and collaboration skills.
Benefits:
This role offers the opportunity to work on high-priority projects, contribute to process improvements, and advance your career in a dynamic organization.
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