Senior Technical Writer (North Haven)

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.