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.
Senior Technical Writer in North Haven at Entegee
This position is listed as contract and hybrid. It was posted 2 days ago.