Senior Technical Writer

12+ Months Contract with a potential to go Direct

Hybrid

Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.

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. xhqgsiq
• Experience in regulated environments with established quality processes.