Technical Writer

Overview

Create and maintain technical documentation, reports, and regulatory files for dental medical devices.

Key Responsibilities

• documentation
• regulatory filing
• design files
• ifu updates
• protocol generation
• technical reports

Tasks

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

Requirements

• iso 9001
• bom
• fda
• medical device
• six sigma
• 3 years

What You Bring

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

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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.

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