1. Regina (Reggie) Hargitt
Phone: 612-716-1869 E-Mail: reggie.hargitt@gmail.com
7/3/15
Summary
Skilled medical device professional with 25+ years of experience developing labeling, instruction for use manuals
and patient education materials as well as labeling documentation control. Proficient working in a fast moving
highly regulated environment that demands quick response and attention to detail. Looking for a position that
utilizes my experience supporting projects that require understanding of product development in a regulated
environment and new opportunities as well.
Skills
Quality assurance Multilingual labeling
Exceptional organizational skills Project planning and development
Subject matter expert Employee training and development
Communication and interpersonal skills Regulated environment
Professional experience
Labeling development and design
§ Produced labeling in manufacturing software systems
§ Labeling for product release, clinical and regulatory submission
§ Instructions for use manual format design and production
§ Labeling design changes and upgrades to improve manufacturing and customer service
§ 20+ years management of translation processes and vendor resources for labeling, manuals and patient
literature
§ Computer programs – Word, Excel, Outlook, PowerPoint, Visio, SharePoint, Windchill, InDesign,
Illustrator, Photoshop
Quality systems and regulatory environment
§ Developed and maintained department processes to comply with domestic and international regulations
including 21 CFR 820, ISO 13485, Medical Device Directive and 21 CFR Part 11
§ Participated as subject matter expert for internal quality audits as well as audits with the FDA and
international notified bodies
§ Established updated department documentation (SOPs) to improve customer service as well as clarify
and improve work processes
§ Lead and participated in teams for continuous improvement projects as well as corrective and
preventative actions (CAPA)
Project and resource management
§ Daily organization of projects and priorities
§ Skilled at team communication and planning
§ Supervise (20+ years) Label Design Team and Labeling Documentation Specialists
§ Generated and executed training for employee and internal customer education
Work history
Boston Scientific, August 1985 to March 2014
Education
University of Minnesota, 2 years + course work - Interior Design/Architecture
University of St Thomas, Project Management