Position Title: Technical Writer
Location: Monroeville, PA
Duration: 12 months
Experience: More than 5 years professional experience.
Education: Bachelor's Degree or equivalent.
Demonstrable excellence in command of the English Language required.
Strong organizational and project management skills required.
Mastery of page layout, word processing, and computer-generated illustrating using the following tools:
Work independently on Technical Writing duties, processes and roles outlined below:
Creates, revises, reviews, and approves medical device labeling to meet requirements of the new EU Medical Device Regulations (EU MDR). Labeling includes, but is not limited to, User Manuals, Provider Manuals, Quick Start Guides, Help Files, Product Labels, and Packaging Labels. Leads formal technical reviews for labeling.
Prepares and updates the labeling plan, labeling-related standard requirements mapping and executes the plans, as needed.
Supports Unique Device Identification (UDI) requirements for the labeling.
Partners with Translation Coordinator(s) throughout the execution of the associated labeling plans.
Supports Quality Management System (QMS) updates related to labeling for compliance with the EU MDR.
Supports internal and external quality audits related to labeling, as needed.