Technical Writer

Overview

Create and maintain technical documentation and regulatory submissions for medical devices.

Key Responsibilities

• documentation
• protocols
• test methods
• design history
• regulatory submissions
• ifu updates

Tasks

-Deliver high-quality documentation and in-product text updates. -Generate protocols, technical reports, test methods, and manufacturing instructions. -Revise and update instructions for use (IFUs), manuals, brochures, and other documentation. -Create, update, and maintain design history files and technical submission files. -Coordinate with the regulatory team on technical file submissions and approval processes.

Requirements

• iso 9001
• six sigma
• fda
• bom
• medical device
• 5 whys

What You Bring

-2-3 professional references -Understanding of the 5 Y's methodology -Minimum of three years of direct documentation experience in manufacturing or related industry -Knowledge of ISO 9001 -Strong writing skills -Familiarity with the dental industry is preferred -Lean Six Sigma certification -Knowledge of BOM and design history files -4-5 brief bullet points highlighting technical qualifications -Experience with FDA regulations -Word copy of resume -Experience in the medical device industry

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About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms