Runjhun Bhargava
Summary:
Motivated Senior Graphics Labeling Specialist with five-plus years in the medical device manufacturing industry, experienced with the design and modification of new and existing graphics, utilizing platforms such as Loftware to manage the full product lifecycle. Familiar with FDA 21 CFR, Directions For Use (DFU), Instructions For Use (IFU), Content Management Systems (CMS) and Adobe Suite. Excellent communicator, leveraging technical, business, and creative acumen to cross-communicate and collaborate effectively with the respective teams.
Skills:
Labeling Graphics and Artwork, FDA 21 CFR, Directions For Use (DFU), Instructions For Use (IFU), Medical Device Labeling, EU-MDR, IDXML, Content Management System (CMS), Change Requests, Illustrations, SDL, Loftware, End-to-End Product Lifecycle, Artwork Management, Computer-generated Labels, Adobe Creative Cloud, Adobe Illustrator, Photoshop, InDesign, Electronic-IFU (eIFU), Task Uploads, PLM, Cross-functional Communication, Microsoft Office, Commercial Printing Equipment, Film, Photography, Fiery Workflow, Scanning, Bindery, Packaging
Professional Experience:
Edwards Lifesciences - Irvine, CA August 2019 - Present
Senior Graphics Labeling Specialist
Process, design and construct medical-based changes in labeling software, within Edwards standards.
Develop new and establish labeling artwork/design in support of new product launches and sustaining projects for domestic and global business at Edwards Lifesciences.
Ensure appropriate and necessary labeling to meet regulatory requirements, with focus on sustaining products.
Design and implementation of content for Directions For Use (DFU) and Instructions For Use (IFU).
Construct design utilizing Adobe Creative suite and the IDXML output from CMS.
Execute simple design change requests (e.g., illustrations), using SDL and Loftware solutions, an end-to-end product lifecycle platform for labeling and artwork management.
Design labels using computer generated labels.
Use the full Adobe suite, including Adobe Illustrator, Photoshop and InDesign used for design concepts.
Implement redline content data with Content Management System (CMS) to create and output Electronic-IFU (eIFU) standard documents for global use requirements.
Utilize CMS designs for medical device labeling and package labeling.
Provide task uploads to ignite PLM system and FTP uploads to the vendors as needed.
Implement EU MDR, structural content and graphic design changes to be compliant with European market changes.
NOCCCD - Fullerton, CA March 2015 - Present
Publication Technician (part-time) (February 2016 - Present)
Interim Instructor Assistant and aide to Printing Department of Fullerton College.
Managed multiple department requests, including the instruction of printing instructors and students.
Supervision and maintenance of large format printers, plotters, and digital presses.
Responsible for the production and requests of live job orders, including the completion of bindery services.
Administrative Assistant (March 2015 - June 2015)
Assisted in the Office of Special Programs.
Master Arts, Inc. - Anaheim, CA December 2014 - January 2015
Graphic Prepress Artist (temporary assignment)
Prepared graphic files and corrected various layouts for templates prior to plates being processed.
Education:
California State University - Fullerton, CA
BA Communications - Radio, TV, and Film
AS - Graphic and Printing Equipment Technology
Certification:
Certified by PIA for Electronic Prepress Level 1
Certificate program for General Printing Technology and Electronic Imaging
