Senior Technical Writer
Full-time
Entegee
12+ Months Contract with a potential to go Direct
Hybrid
Overview
Develop and update medical device labeling and Instructions for Use (IFUs) to meet regulatory and quality requirements.
Responsibilities
- Write and update IFUs based on cross-functional feedback and applicable standards.
- Manage labeling approvals, Engineering Change Orders, translations, and product launch distribution.
- Review labeling proofs and support regulatory submissions, CAPAs, and audits.
- Collaborate with cross-functional teams to complete labeling deliverables.
Requirements
- Bachelor’s degree with relevant experience.
- Medical device labeling and CAPA experience.
- Experience with InDesign, FrameMaker, XML tools, or similar authoring tools.
- Experience in regulated environments with established quality processes.
Vacancy posted 1 hour ago
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