We're looking for a Tech Writer with experienced in an FDA regulated environment in Monroeville--1+ year contract opportunity.
Demonstrable excellence in command of the English Language required.
Strong organizational and project management skills required.
location: Monroeville, Pennsylvania
job type: Contract
salary: $40 - 45 per hour
work hours: 8am to 5pm
Work independently on Technical Writing duties, processes and roles outlined below:
1. 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.
2. Prepares and updates the labeling plan, labeling-related standard requirements mapping and executes the plans, as needed.
3. Supports Unique Device Identification (UDI) requirements for the labeling.
4. Partners with Translation Coordinator(s) throughout the execution of the associated labeling plans.
5. Supports Quality Management System (QMS) updates related to labeling for compliance with the EU MDR.
6. Supports internal and external quality audits related to labeling, as needed.
Experience: More than 5 years professional experience.
Education: Bachelor's Degree or equivalent.
skills: Mastery of page layout, word processing, and computer-generated illustrating using the following tools:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.