Position Summary & Responsibilities:

The Technical Writer is responsible for the development, revision, and control of product labeling deliverables (user manuals, instructions for use, and labels) in a Content Management System. This role supports reagents, accessories, and software both during the product 98development process and Lifecyle Management. During this process, the Technical Writer will write/update, review, and finalize labeling deliverable according to regulatory standards and requirements.

• Participates in cross-functional projects and communicating effectively with internal customers and management to ensure timelines and objectives are achieved.

• Executes design control processes to define labeling requirements and provide traceability.

• Understand and apply regulations as they apply to labeling.

• Responsible for consolidating and reconciling all comments from the internal reviewers; facilitating review meetings if necessary.

• Track and implement change requests, anomalies, issues, and requirements logged against labeling deliverables.

  Education, Skills, & Experience:

• Bachelor’s degree in technical writing/communication or a scientific/technical degree with 2+ years’ experience in technical writing.

• High School Diploma with 6+ years of technical writing experience also accepted

• Associate’s Degree with 4+ years of technical writing experience also accepted

• Experience with structured authoring with XML and Component Content Management System.

• Professional experience in documentation development is essential.

• Medical devices or other regulated environment strongly recommended. ​​​​​​​

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