Immediate need for a talented Technical Writing- Medical Devices. This is a 06+ Months Contract opportunity with long-term potential and is located in Milpitas, CA (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID:26-29189
Pay Range: $50 - $55/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- The Technical Writer / Proofreader is responsible for creating, editing, proofreading, maintaining, and controlling regulatory-compliant product labeling and technical documentation for medical device and in vitro diagnostic (IVD) products.
- This role ensures documentation is accurate, clear, compliant, and aligned with corporate branding, Quality Management System (QMS) requirements, and global regulatory standards.
- The position works closely with Regulatory Affairs, Quality, R&D, Marketing, Manufacturing, Product Management, and Operations teams to develop high-quality customer-facing documentation and labeling throughout the product lifecycle.
- Technical Writing
- Create, revise, and maintain technical and regulatory documentation including:
- Instructions for Use (IFUs)
- Package Inserts
- Product Labels
- Quick Reference Guides
- User Manuals
- Installation and Operating Manuals
- Technical Data Sheets (TDS)
- Release Notes
- eIFU Content
- Packaging Documentation
- Convert complex scientific, engineering, and regulatory information into clear, concise, and user-friendly documentation.
- Collaborate with subject matter experts to gather, organize, and communicate technical information.
- Develop structured documentation using single-sourcing and content reuse methodologies.
- Support document change control activities and lifecycle management processes.
- Facilitate and participate in cross-functional reviews to ensure accuracy and completeness.
- Manage multiple documentation projects while meeting established timelines.
- Support continuous improvement initiatives related to documentation quality, content management, and user experience.
- Proofreading & Editing
- Perform detailed proofreading of technical documentation, labeling artwork, and customer-facing materials.
- Verify grammar, spelling, punctuation, terminology, consistency, and readability.
- Ensure compliance with approved style guides, templates, branding standards, and corporate requirements.
- Review formatting, layout, hyperlinks, references, tables, graphics, and document structure.
- Verify documentation complies with applicable regulatory and quality requirements.
- Review translated documentation for consistency with approved English source content and formatting standards.
- Identify and correct content discrepancies, formatting errors, and document defects before release.
- Ensure documentation meets accessibility and usability requirements where applicable.
Key Requirements and Technology Experience:
- Core Must-Have Skills:
- MadCap Flare REQUIRED
- Medical Device / IVD / Regulated Industry Technical Writing
- Regulatory & Quality Documentation
- Practical exposure to FDA 21 CFR 801/820, EU MDR/IVDR, ISO 20417, ISO 18113, ISO 15223-1, IEC 62366.
- Proofreading / Document Quality
- Structured Authoring / Content Management
- Education:
- Bachelor's degree in Technical Writing, English, Communications, Journalism, Life Sciences, Biotechnology, Engineering, or a related field.
- Equivalent combination of education and relevant experience may be considered.
- Experience:
- 5+ years of experience in technical writing, editing, or proofreading.
- Experience developing technical documentation in a regulated industry.
- Experience managing document review and approval workflows.
- Medical device, IVD, pharmaceutical, biotechnology, or other regulated industry experience preferred.
- Required Technical Skills:
- Authoring & Documentation Tools
- MadCap Flare (Required)
- Adobe FrameMaker
- Microsoft Word, Excel, PowerPoint, Teams, and Outlook
- Adobe Acrobat Pro
- Adobe Illustrator
- Adobe InDesign
- Document Management Systems (DMS)
- Content Management Systems (CMS)
- Technical Knowledge
- Structured authoring and single-sourcing methodologies
- Revision control and document lifecycle management
- XML, HTML, and CSS fundamentals
- Translation and localization workflows
- Regulatory document management systems
- SAP or equivalent enterprise systems preferred
- Regulatory & Industry Knowledge
- Working knowledge of:
- FDA 21 CFR Part 801
- FDA 21 CFR Part 820
- EU MDR
- EU IVDR
- ISO 20417
- ISO 18113 Series
- ISO 15223-1
- IEC 62366
- Labeling and documentation requirements for medical devices and in vitro diagnostics
- Core Competencies:
- Technical Writing
- Proofreading and Copy Editing
- Attention to Detail
- Regulatory Compliance
- Documentation Quality Assurance
- Project Management
- Cross-Functional Collaboration
- Content Development
- Critical Thinking
- Time Management
- Problem Solving
- Written Communication
- Document Lifecycle Management
- Advanced proficiency with MadCap Flare.
- Experience with Adobe FrameMaker in a regulated environment.
- Experience supporting global labeling and multilingual documentation.
- Experience developing content for medical devices, software, diagnostics, or laboratory instrumentation.
- Knowledge of eIFU and digital labeling solutions.
- Experience with content reuse strategies, modular documentation, and content architecture.
Our client is a leading Medical Devices Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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