Technical Writer
ATR International
Position Overview
We are seeking a Technical Writer to support our CST Technical Communication team. In this role, you will author, revise, and manage Instructions for Use (IFUs) and electronic IFUs (eIFUs) within a regulated medical device environment. You will work extensively with structured XML authoring tools and component content management systems (CCMS), perform change effect analyses, coordinate localization workflows, and partner with cross-functional teams (R&D, Regulatory, Quality, Software Packaging/Testing) to deliver critical technical documentation on time.
Key Responsibilities
Content Authoring & Revision: Author and update technical documentation, including IFUs and eIFUs, in structured XML (DITA-like formats).
Content Management & Publishing: Manage source content through CMS workflows and the quality system publishing pipeline to ensure seamless releases.
Impact & Change Analysis: Perform thorough IFU change effect analysis and requirements traceability to maintain regulatory compliance.
Localization Coordination: Support translation and localization review workflows across global regulatory regions.
Cross-Functional Collaboration: Partner with R&D, Regulatory Affairs, Quality Assurance, and Software Packaging/Testing teams to support medical device product releases on schedule.
Required Qualifications & Top Skills
Education & Experience
Education: Bachelor’s Degree (Technical Writing, English, Communications, Engineering, or a related field).
Experience: 5+ years of technical writing experience in a structured, regulated production environment.
Top 3 Required Technical Skills
Structured Authoring & CMS: Demonstrated expertise with structured authoring tools (Structured FrameMaker, Oxygen XML Editor, or comparable) and CMS-based content management.
Medical Device IFU Development: Proven experience developing technical communications and IFUs within a regulated medical device or life-sciences framework.
Quality System Processes: In-depth familiarity with quality system workflows, including change effect analysis, requirements traceability, and translation/localization pipelines.
Must-Have Skills
Deep expertise in Adobe FrameMaker (specifically Structured FrameMaker).
Strong capability in managing and editing structured markup languages (XML, HTML).
Hands-on experience with professional publishing tools and documentation lifecycles.
Preferred Qualifications (Nice-To-Have)
Experience with Vasont Content Management System (CMS).
Proficiency with Adobe Creative Cloud applications (Adobe Illustrator, Adobe InDesign, Adobe Photoshop).
Background supporting active medical device releases under strict regulatory oversight.
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