ZipRecruiter
161159 - Technical Writing Specialist (Class II Medical Devices)
ZipRecruiter, San Diego, California, United States, 92189
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.
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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.
#J-18808-Ljbffr