Job Title: Senior Technical Writer
Location: Remote (U.S.)
Position Overview: Seeking a seasoned Senior Technical Writer with extensive experience in the medical device industry to join my client's team. This role will be critical in developing, editing, and maintaining comprehensive documentation for their medical technology products. The ideal candidate will have a strong background in technical writing, including XML and DITA standards, API documentation, and content management systems, as well as a deep understanding of design control and regulatory requirements.
Key Responsibilities:
- Documentation Development: Create, edit, and maintain detailed and accurate documentation for medical devices, including user manuals, installation guides, technical specifications, and regulatory submissions.
- XML & DITA Expertise: Utilize XML and DITA to structure and manage content efficiently. Develop and maintain DITA-based documentation and ensure adherence to XML standards.
- API Documentation: Generate clear and comprehensive API documentation to support developers and ensure proper integration with our medical devices.
- Regulatory Compliance: Ensure all documentation complies with regulatory standards (e.g., FDA, ISO) and industry guidelines. Stay current with changes in regulations and integrate them into documentation practices.
- Content Management: Use content management systems (CMS) to organize, version, and maintain documentation. Develop and implement best practices for content management and ensure consistency across all documentation.
- Design Control: Work within design control processes to document design history files (DHF), design input and output, and other related documentation requirements.
- Cross-Functional Collaboration: Collaborate with engineers, product managers, compliance officers, and other stakeholders to gather and verify technical information, ensuring documentation accuracy and completeness.
- Quality Assurance: Review and revise documentation to ensure clarity, consistency, and technical accuracy. Incorporate feedback from internal reviews and user testing.
- Project Management: Manage multiple documentation projects simultaneously, prioritize tasks effectively, and meet deadlines.
Qualifications:
- Minimum of 7 years of experience in technical writing, with a strong focus on medical device documentation.
Don't hesitate to apply today!
