- In this role, the technical writer will be responsible for collaborating with the in-house project team as well as offshore resources to support new product development and sustaining projects
- They will be responsible for the generation of Information for Use (IFU) documents and other end-user documents localized into multiple languages, as well as product label creation and release
- They will coordinate and drive localization efforts via third party suppliers
- Develop a thorough understanding of ophthalmic diagnostic devices and software applications to produce effective, well-written user manuals
- Coordinate with third party vendors to scope, develop and deliver documentation, labeling and translation deliverables across different projects
- Drive streamlining of technical writing and localization processes, and lead continual improvement activities for the team
- Participate in the ongoing Digital Transformation efforts
- Scope, plan and execute projects which include generation, review and release of end-user documents in accordance with business priorities
- Coordinate the release of product labels including instructions for use, quick start guides, device markings, package labels, artwork, and other user-facing documentation
- Coordinate the review of product labeling against market regulations and industry performance standards to determine compliance and fitness for release to markets
- Ensure that the product literature and labeling are consistent, clear, technically accurate, complete, and meet regulatory, marketing, and branding requirements
- Organize and facilitate content and quality reviews of the literature and labeling
- Proactively communicate with all relevant parties and manage timelines and deadlines for documentation projects
- Ensure regulatory compliance, accuracy, timely completion, and version control of all new and revised labels
- Comply with relevant Standard Operating Procedures (SOP) and closely monitor activities to maintain regulatory compliance
Employees holding this position will be required to perform any other job-related duties as requested by management and will also be required to meet safety-related requirements