Senior Technical Writer

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Oversee the creation of technical documentation and labeling outputs for initiatives related to new product development, maintenance, quality assurance, regulatory compliance, and business integration.

• Create and uphold compliant labeling solutions that adhere to regulatory standards and quality system protocols.

• Supervise labeling requirements and content across various labeling systems.

• Write manuals and technical documents while collaborating with label designers to ensure product labels are accurate and compliant.

• Collaborate with cross-functional teams to establish documentation strategies and provide high-quality labeling solutions.

• Lead documentation and labeling processes throughout all stages of the product lifecycle.

• Conduct assessments of labeling and documentation for new product launches, product modifications, quality initiatives, and regulatory compliance efforts.

• Assist with engineering change requests, product transfers, remediations, non-conformance/corrective action (NC/CAPA) processes, and continuous improvement initiatives.

• Employ content management systems, structured authoring methodologies, and best practices in documentation.

• Identify potential risks, address issues, and drive projects and tasks to successful completion.

⛳️ Requirements

• Bachelor's degree in Technical Writing, Communications, or a related discipline.

• At least 2+ years of experience in technical writing within the medical device sector.

• Expertise in DITA XML authoring and structured content development using content management systems.

• Familiarity with technical documentation platforms and product lifecycle management (PLM) tools, such as Arbortext and Windchill.

• Knowledge of translation workflows and global documentation standards for regulatory compliance.

• Experience in cross-functional project teams, working alongside subject matter experts (SMEs) to gather, analyze, and integrate technical requirements and feedback.

🏝️ Benefits

• Flexibility to work remotely, in a hybrid model, or onsite.

• 10% travel requirement.

• Commitment to equal opportunity employment.