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Ramona Denton

 

 

Ramona Denton
Senior Technical Writer & Documentation Specialist | Remote

Medical Device Labeling • Regulatory Documentation • Process Improvement

 

Professional Summary

Technical documentation specialist with 16 years of experience developing and managing regulatory documentation and medical device labeling, including 12 years creating and maintaining Instructions for Use (IFUs) and other controlled documentation. Expertise includes technical writing, editing, proofreading, FDA-compliant labeling, UDI/GUDID implementation, document control, content management, and workflow automation. Proven ability to improve documentation processes, manage multiple concurrent projects, and deliver accurate, compliant documentation in fast-paced, regulated environments.

 

Core Competencies

  • Technical Writing | Editing | Proofreading
  • Medical Device Labeling | Instructions for Use (IFUs)
  • Regulatory Documentation | UDI/GUDID Compliance
  • Document Control | Content Management
  • Process Improvement | Workflow Automation (VBA)
  • Project Coordination | Deadline Management
  • Cross-Functional Collaboration | Training & Mentoring
  • Microsoft Office Suite | Adobe Acrobat Pro

 

Resume

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TEKsystems

Contractor at TEKsystems, working for Hologic

Hologic

Role

  • Created, edited, and maintained user manuals, Instructions for Use (IFUs), and product labeling to ensure accuracy, consistency, and regulatory compliance while reducing the risk of documentation errors.
  • Organized, prioritized, and tracked multiple documentation projects to ensure on-time delivery and cross-functional coordination.

Skills

  • Attention to Detail
  • Proofreading
  • Communication
  • Teamwork
  • MS Word, Excel, PowerPoint
  • Adobe Acrobat Pro, InDesign, Illustrator

uSERP.io

Role

  • Edited and optimized guest articles in a fully remote contract role, improving grammar, clarity, readability, formatting, and SEO while ensuring publication-ready quality.
  • Managed editing assignments independently, consistently meeting deadlines and maintaining high editorial standards.

Skills

  • Communication
  • Link Building
  • Proofreading
  • SEO
  • Teamwork

smartblogger.com

Role

  • Researched, wrote, and edited SEO-optimized blog posts, in a fully remote freelance role, producing well-structured, engaging content designed to improve readability and search visibility.

Skills

  • Communication
  • Content Marketing
  • Copy Editing
  • Proofreading
  • SEO
  • Teamwork
  • Writing

Role

  • Collaborated with senior editors and freelance writers to produce publication-ready blog content in a fast-paced editorial environment.
  • Performed SEO keyword research and developed detailed content briefs to support content strategy and guide article development.
  • Planned, wrote, edited, and optimized blog posts for clarity, engagement, and search engine performance.
  • Produced content that achieved first-page Google search rankings within six months of publication through effective SEO and high-quality editorial practices.

Skills

  • Communication
  • Content Marketing
  • Copy Editing
  • Proofreading
  • Publishing Blog Posts
  • SEO
  • Teamwork
  • Writing

repligen.com

Managed labeling development and production process for a growing number of global sites.

Achievements

  • Designed, developed, and maintained product label templates using BarTender label management software, improving consistency, accuracy, and regulatory compliance.
  • Established global standards for label design and development, driving consistency across products, sites, and documentation.
  • Authored and enhanced procedures and work instructions, improving process clarity, standardization, and operational efficiency.

Skills

  • Communication
  • Content Management
  • Employee Training
  • Leadership
  • Management
  • Microsoft Office
  • Presentations
  • Problem Solving
  • Process Improvement
  • Proofreading
  • Teamwork
  • Technical Documentation
  • Technical Writing
  • Windows OS
  • Writing

hycorbiomedical.com

Coordinated labeling projects for IVD medical devices.

Achievements

  • Designed, developed, and maintained label templates using EasyLabel and BarTender label management software, leveraging database- and scripting-based content management systems to improve accuracy, consistency, and efficiency.
  • Authored, revised, and maintained procedures and work instructions, enhancing process clarity, standardization, and operational effectiveness.
  • Developed and maintained FDA-compliant Unique Device Identifier (UDI) labeling, including human-readable and barcode elements, and managed Global UDI Database (GUDID) registrations to ensure regulatory compliance.
  • Automated document control and operational workflows using VBA macros, developing one-click tools that streamlined change control processes, reduced manual effort, and accelerated email notifications.

Skills

  • Communication
  • Content Management
  • Employee Training
  • Leadership
  • Microsoft Office
  • Microsoft Word & Excel Macros
  • Problem Solving
  • Process Improvement
  • Proofreading
  • Teamwork
  • Technical Documentation
  • Technical Writing
  • Windows OS
  • Writing

hrblock.com

Prepared accurate federal and state income tax returns by analyzing financial information, interviewing clients, and applying current tax laws and regulations.

Skills

  • Communication
  • Microsoft Office
  • Proofreading
  • Sales
  • Tax Preparation
  • Teamwork
  • Technical Documentation
  • Windows OS

Traveled to all 50 States and 100+ nations by motorcycle, car, bus, train, airplane and cruise ship.

Skills

  • A positive, "can-do" attitude
  • Appreciation for different cultures and viewpoints
  • Communication
  • Music Performance (singing, playing piano, guitar, and ukelele)
  • Planning
  • Problem Solving
  • Self Determination
  • Teamwork

siemens.com

Programmer / Analyst III
Programmer / Analyst II

January 2008 – December 2009

Trained and supported the new Translation and Global Changes Coordinator. Shared macro automation strategies with offshore counterparts. Coordinated global IFU changes in 15 languages.

Project Leader
Senior Programmer

April 2006 – December 2007

Role: Provided leadership as groups from three companies merged into one labeling team. Automated the creation, revision, and review of Instructions for Use in 15 languages. Coordinated translations and global projects.

Achievements

  • Updated company name, logos and addresses 4 times in 3 years resulting in 60,000 total document changes.
  • Designed method for proofreading and approval of global changes that reduced time required per complete change from several months to a few weeks.
  • Generated $250-300K of translation value using VBA macros within a $20K budget.
  • Composed software documentation/user manual for VBA macro procedures.

Skills

  • Communication
  • Content Management
  • Employee Training
  • Leadership
  • Microsoft Office
  • Microsoft Word & Excel Macros
  • Problem Solving
  • Process Improvement
  • Proofreading
  • Quality Assurance
  • Teamwork
  • Technical Documentation
  • Technical Writing
  • Windows OS
  • Writing

Role

  • Published time-sensitive email and web updates for mortgage rates and discount programs, ensuring accurate, timely communication to customers and internal stakeholders.
  • Formatted and maintained online documentation using Adobe Acrobat Pro, creating professional, user-friendly documents with extensive hyperlinking and navigation.
  • Managed documentation and web content using SharePoint, Microsoft Excel, and RoboHelp, supporting efficient content organization and publishing workflows.

Skills

  • Communication
  • Content Management
  • Microsoft Office
  • Problem Solving
  • Process Improvement
  • Proofreading
  • Teamwork
  • Technical Documentation
  • Technical Writing
  • Windows OS

DPC is now Siemens

Senior Labeling Specialist
Senior Programmer

January 2002 – September 2005

Automated creation, revision, and review of Instructions for Use in 15 languages. Coordinated translations and global projects. Reviewed and approved product labels. Improved Standard Operating Procedures.

Desktop Publishing Coordinator
Translation Coordinator

September 1996 - December 2001

Wrote, edited, and proofread Instructions for Use in English. Coordinated with European affiliates to assemble IFUs in five European languages. Researched scripting and content management system options in preparation for adding translations, created first multi-language document.

Achievements

  • Created VBA macro to open, revise, and save files without further user intervention, enabling the rapid revision of hundreds of documents daily.
  • Saved team 2 hours per new multi-language insert created, using macros to create Instructions for Use from pre-translated list.
  • Made $10K labeling budget perform like $100K by using pre-translated global text in IFUs, purchasing only rush translations when needed.
  • Saved 15 hours monthly by streamlining review and approval paperwork, accomplishing a 5-minute task in 10-20 seconds.

Skills

  • Communication
  • Content Management
  • Employee Training
  • Leadership
  • Microsoft Office
  • Microsoft Word & Excel Macros
  • Problem Solving
  • Process Improvement
  • Proofreading
  • Teamwork
  • Technical Documentation
  • Technical Writing
  • Windows OS

Sierra Madre Congregational Church is now Christ Church Sierra Madre

Role

  • Managed the production of printed materials, coordinating print jobs from file preparation through final finishing while ensuring quality and timely delivery.
  • Operated, maintained, and troubleshot printing and finishing equipment to support efficient, high-quality production.
  • Managed printing supply inventory and procurement to maintain uninterrupted production operations.
  • Provided proofreading, graphic design, desktop publishing, and print production support for church staff and ministry departments.

Skills

  • Aldus/Adobe Pagemaker (precursor to Adobe InDesign)
  • Apple Mac OS
  • Communication
  • Inventory Control
  • Microsoft Office
  • Pre- & Post-Press Operations (Platemaking, Cutting, Folding, Collating, Finishing)
  • Printing Press Operation &: Maintenance (AB Dick 360)
  • Problem Solving
  • Proofreading
  • Teamwork

DPC is now Siemens

Print Shop Supervisor
January 1985 – December 1986

Trained and supervised Print Shop personnel. Organized, inventoried and produced printed materials. Operated and maintained printing equipment, high-speed photocopier, dark room and dark room equipment.

Print Shop
July 1982 - December 1984

Organized, inventoried and produced printed materials. Operated and maintained printing equipment, high-speed photocopier, dark room and dark room equipment.

Achievements

  • Streamlined initial quality check and inventory control for IFUs, by implementing a quality checking procedure, that included document review, shrink-wrapping and labeling in packs of 50.
  • Reduced cost of printing colored covers for Instructions for Use (IFUs), by pre-printing color-coded cover "blanks" and adding the document title on demand, when the body of the document was printed on a high-speed photo copier.
  • Reduced the number of covers needed in stock to only 5 types of covers, one for each product line, instead of over 100 different covers, one for each product.

Skills

  • Communication
  • Employee Training
  • Inventory Control
  • Microsoft Office
  • Photocopier Key Operator (Xerox & Kodak)
  • Pre- & Post-Press Operations (Platemaking, Cutting, Folding, Collating, Finishing)
  • Printing Press Operation & Maintenance (Ryobi)
  • Problem Solving
  • Process Improvement
  • Teamwork
  • Typesetting (MCS100)
  • Windows OS

Pasadena City College
Pasadena, California

Major: English and German
32 Semester Units completed toward Associate of Arts Degree
 

California Polytechnic State University
San Luis Obispo, California

Major: Graphic Communications
47 Quarter Units completed toward Bachelor of Science Degree
 

Claremont High School
Claremont, California
Graduate

Recognition
Outstanding Student of the Year, English Department
Oustanding Contribution as Yearbook Editor