161159 - Technical Writing Specialist (Class II Medical Devices) Job at ZipRecru

Overview

Technical Writing Specialist (Class II Medical Devices) – San Diego, CA. Pay Rate: $48.51/hr. Location: San Diego, CA (Local candidates only). Employment Type: Contract | Full-time | Potential contract-to-hire.

Job Summary

We are seeking an experienced Technical Writing Specialist to join our team supporting Class II medical devices. The ideal candidate has strong technical writing expertise, deep knowledge of medical device regulatory requirements, and experience collaborating across engineering, quality, and regulatory teams.

You will be responsible for creating, editing, and maintaining technical documentation that supports both regulatory submissions and end-user needs while ensuring clarity, compliance, and accuracy.

Responsibilities

• Develop, edit, and maintain technical documentation including user manuals, installation guides, troubleshooting guides, IFUs, and regulatory submission materials.
• Ensure all documentation complies with FDA, ISO, and other applicable regulatory standards.
• Create and edit illustrations, diagrams, line art, and product photos to support documentation clarity.
• Partner with engineering, QA, regulatory affairs, clinical affairs, marketing, and customer support to gather technical content.
• Review and improve technical content for readability, clarity, and style.
• Develop and maintain style guides, templates, and documentation standards.
• Stay current with regulatory requirements and industry best practices.
• Mentor junior writers and support cross-functional documentation projects.
• Manage documentation timelines, priorities, and resources to meet project deliverables.

Qualifications

• 5+ years of experience in technical writing for medical devices, pharmaceuticals, or another regulated industry.
• Extensive experience with regulatory compliance processes and supporting FDA submissions.
• Strong collaboration skills with marketing, quality, regulatory, and engineering stakeholders.
• Expertise in developing hardware/software user guides for both print and online platforms.
• Experience in device labeling and packaging content development.
• Familiarity with electro-mechanical concepts and software applications.
• Proficient in documentation tools such as MadCap Flare, Adobe FrameMaker, InDesign, Illustrator, XML, DITA.
• Skilled in Acrobat, MS Word (tracked changes), and proofreading/editing standards.
• Knowledge of version control systems (GitHub, Subversion, Team Foundation Server, Perforce).
• Familiarity with ERP systems (SAP, Oracle).
• Photo editing skills with Adobe Photoshop a plus.
• Strong project management skills with ability to juggle multiple priorities under tight deadlines.

Skills

• Experience with Agile development methodologies.
• Knowledge of engineering change control processes in large organizations.
• Ability to work independently with minimal supervision while thriving in a fast-paced environment.

This position offers the opportunity to work on life-impacting products while collaborating with top professionals across engineering, regulatory, and quality functions.