Develop product instructions for use and customer‑facing documentation that is accurate, compliant, and translation‑ready for global users.
Plan, write, and deliver labeling content using technical publishing tools while managing project timelines and deliverables.
Drive labeling activities as an active project team member, ensuring documentation meets medical device regulations and internal quality system requirements.
Coordinate cross‑functional input from engineers, clinicians, and subject matter experts to create technically sound and user‑centered content.
Evaluate and improve documentation quality by interpreting procedures, incorporating labeling standards, and applying topic‑based authoring strategies.
Perform Labeling Specification, Verification, and Global Impact Assessment reviews, applying critical thinking to assess cross‑functional effects of changes.
Manage multiple concurrent projects, escalating issues when needed to maintain compliance and readiness.
Contribute to process improvements, product transfers, and quality system integration efforts, and mentor less experienced writers when appropriate.
Requirements
Bachelor’s degree in Technical Writing, Technical Communications, or related field
Minimum 2 years of work experience in technical writing or a related discipline
Experience working in a regulated industry (minimum 2 years preferred)
Experience with topic based authoring or DITA
Experience using enterprise content management systems
Experience with product lifecycle management systems
Experience with Adobe Creative Suite and Microsoft Office tools