Writes and maintains design history file records for medical device product labeling development. Maintains project tracking records. Prepares and submits product labeling proofing packaging and review forms. Scans and uploads completed review documentation for ECR/ECO release. Coordinates instructions for use templates and standard text document revisions through designated review and approval process. Participates in cross-functional instruction for use collaborative and technical reviews, documenting changes and decisions. Manages and coordinates writing and release of technical documentation including Declaration of Traceability documents, Clinical Laboratory Standards Institute procedures, and sample handler stability instruction.

Assists in writing, editing and maintaining technical documentation, including assay instructions for use and other technical publications from document plans and style guides. Assists in the research of technical information, including design specifications, through interviews with subject matter experts.

May assist in routine phases of document development cycle, including project scope and requirements, documentation design, etc.

Requirements:

·         Proficient in Word, Excel and Acrobat.

·         1-3 years working experience in technical writing in the medical device, pharmaceutical or similar industry.

·         Working experience in XML or HTML, content management and maintaining design history file documentation required.

·         Must be detail oriented, process oriented and well organized.

Working experience and knowledge of the following not required, but preferred:

SAP, Teamspace, FDA and ISO design control requirements.