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
Resume
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Contractor at TEKsystems, working for Hologic
Role
Skills
Role
Skills
Role
Skills
Role
Skills
Managed labeling development and production process for a growing number of global sites.
Achievements
Skills
Coordinated labeling projects for IVD medical devices.
Achievements
Skills
Prepared accurate federal and state income tax returns by analyzing financial information, interviewing clients, and applying current tax laws and regulations.
Skills
Traveled to all 50 States and 100+ nations by motorcycle, car, bus, train, airplane and cruise ship.
Skills
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
Skills
Role
Skills
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
Skills
Sierra Madre Congregational Church is now Christ Church Sierra Madre
Role
Skills
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
Skills
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