Job Description

• The Technical Writer will be responsible for developing, writing, and maintaining comprehensive technical documentation for our Class II medical devices. This role requires a detail-oriented professional with strong writing skills and a deep understanding of regulatory requirements.
• The ideal candidate will have extensive experience in the medical device industry and the ability to work effectively with cross-functional teams.

Key Responsibilities:

• Create, edit, and maintain customer and internal facing technical documentation, including user manuals, installation guides, troubleshooting guide, upgrade/downgrade instructions for various country regulatory submissions.
• Ensure all documentation meets regulatory requirements, industry standards, and company policies.
• Create illustrations, flow charts, diagrams, line art, in addition to product photos for both quality and technical documentation. Provide recommendations to engineers on optimizing engineering data expressed in graphs, illustrations, and tables to ensure clarity and consistency.
• Review and edit technical documents for clarity, accuracy, and compliance.
• Stay current with industry trends, regulatory changes, and best practices in technical writing and medical device documentation.

Qualifications:

• Experience working in a regulated industry such as medical devices or pharmaceuticals.
• Extensive experience with regulatory compliance processes. Strong background in supporting regulatory requirements to ensure adherence to regulatory guidelines.
• Five or more years writing and editing hardware/software user guides (print and online) and other technical product documentation.
• Experience in device labeling and/or packaging content development.
• Experience with SAP, Oracle, or similar enterprise resource planning (ERP) system is a plus.
• Experience in version control systems (VCS) such as, Perforce, Apache Subversion, Microsoft Team Foundation Server, or GitHub.

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