Supports product development teams by independently developing product instructional materials for complex medical devices or product lines. Deliverables may include product instructions for use, Quick Guides, online help, and other product-related customer-facing documentation, along with usability analysis of these deliverables. The audience includes physicians, healthcare staff, facility engineers, and patients on a global scale. All deliverables must comply with medical device regulations, standards, and business requirements.
Responsibilities:
1. Develop customer-facing product instructional information for an entire business unit, adhering to user needs and regulatory requirements for both domestic and international customers.
2. Collaborate cross-functionally within the product development team to gather source materials and deepen product understanding.
3. Interview and gather information from Subject Matter Experts (SMEs) from R&D, Regulatory Affairs, and other functional areas.
4. Write and edit Instructions For Use (IFUs), Quick Start Guides, and related documents, ensuring content aligns with product labels.
5. Participate in new product development meetings to capture inputs, project deliverables, and product specifications.
6. Plan and track workload and projects effectively, understanding critical paths and interdependencies in a multi-project environment, and communicate timelines clearly.
7. Manage multiple complex projects to meet milestones.
8. Work with Graphic Designers to incorporate graphical elements for instructional clarity and international applicability.
9. Contribute to departmental continuous improvement initiatives.
10. Review and edit colleagues' work within the functional area.
11. Train team members as needed.
12. Review regulatory documentation to ensure medical device labeling is complete, correct, and compliant with FDA and EU standards.
13. Manage IFUs within PLM/CMS systems for controlled releases and revisions.
14. Complete necessary QMS documentation as per regulatory and change management processes.
15. Possibly own Non-Conformance (NCs) and Corrective and Preventive Actions (CAPAs).
16. Assist with regulatory audits as required.
17. Lead and participate in team improvement projects.
Qualifications & Experience:
* At least 2 years of relevant Technical Writing experience.
* Bachelor's degree in English, Technical Writing, Communication, or a related field preferred.
* Ability to work effectively under pressure in a fast-paced environment.
* Strong understanding of IFU concepts, practices, and procedures.
* Attention to detail with the ability to manage multiple projects simultaneously.
* Excellent organizational and time management skills.
* Ability to quickly learn new software and technologies.
* Strong problem-solving and analytical skills.
* Experience with change management processes.
* Interest and understanding of language translation and international communication, including impact on format design.
* Experience with regulated industries or environments requiring high attention to detail.
* Proficiency with Adobe Illustrator, XML, and enterprise CMS systems is preferred.
Travel Percentage: 10%
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