**Product Instructional Specialist**
The Product Instructional Specialist plays a crucial role in supporting product development teams by creating high-quality instructional materials for complex medical devices or product lines. The specialist's deliverables may include product instructions for use, Quick Guides, online help, and other product-related customer-facing documentation.
The primary audience for these materials includes physicians, healthcare staff, facility engineers, and patients globally. To ensure compliance with medical device regulations, standards, and business requirements, the specialist must thoroughly understand user needs and regulatory requirements for domestic and international customers.
The specialist will work closely with cross-functional teams to acquire source materials, develop a deep understanding of products, and collect information from Subject Matter Experts (SMEs) from R&D, RA, and various functional areas.
The key responsibilities of this role include:
* Developing customer-facing product instructional information for an entire business unit according to user needs and regulatory requirements for domestic and international customers.
* Interface cross-functionally within the product development team to acquire source materials and develop understanding of the products.
* Interview and collect information from SMEs from R&D, RA, various functional areas.
* Write and edit Instructions For Use (IFUs), Quick Start Guides, and other accompanying documents aligning content with associated product labels.
* Participate in new product development meetings with cross-functional team members to capture inputs, project deliverables, and product specifications.
* Effectively plan and track workload and projects understanding the critical path and interdependencies in a multi-project environment while effectively communicating timelines with project teams.
* Manage multiple assignments for complex projects to meet project milestones.
* Collaborate with the Graphic Designer to incorporate graphical elements for instructional purposes and accurate interpretation and international application.
* Drive and assist with departmental continuous improvement endeavors.
* Review and edit on the work of others prepared work within functional area.
* Train members of our functional team.
* Provide reviews of regulatory documentation to ensure that medical device labeling references are complete and correct and compliant with FDA and EU requirements.
* Manage IFUs PLM/CMS system for controlled releases and revision management.
* Complete applicable QMS documentation as required by the regulatory and change management process.
The ideal candidate will possess:
* 2+ years of applicable Technical Writing experience.
* Bachelor's degree required (English, Technical Writing, Technical Communication, Communication, or related curriculum preferred).
* Ability to work under pressure in a fast-paced environment.
* Able to apply fundamental and advanced concepts, practices, and procedures related to IFUs.
* Detail-oriented with the ability to manage multiple simultaneous projects while providing collaborative customer service.
* Strong organizational and time management practices.
* Able to prioritize and work within schedules.
* Must be able to understand and apply advanced technology applied to technical area.
* Excellent problem-solving and analytical ability.
* Experience with a rigorous change management process.
* Interest in language translation and international communication.
* Understanding of impact of language translation to format design.
* Ability to work under pressure in a fast-paced environment.
* The ability to quickly learn new software.
**Preferred Experience:**
* Previous work experience within a regulated industry or in an industry where attention to detail is required.
* Experience with Adobe Illustrator, XML, and enterprise CMS system.