"Alerted.org

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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