Project Design
Resume:
Sean Lee
San Marcos, CA **078
******@*****.***
CAREER SUMMARY
Highly motivated, action-oriented regulatory marketing material support
or document / Labeling handling professional with a proven track record
of successful accomplishments in medical device field.
PROFESSIONAL EXPERIENCE
August 2012 - Present Edwards Lifesciences LLC Irvine,
CA
Global Label Development
Sr. Labeling Associate
. Working under highly regulated Federal Drug Administration
("FDA") environment in the Labeling department.
. Redline existing labeling documents or create new labeling
. Create and route labeling "Enterprise Change Request (ECR)" for
labeling implementation.
. Create and control label inventory with using Oracle's JD
Enterprise system.
. Ensures project team to determine artwork/labeling specifications
according to the each model numbers.
. Responsible for labeling CAPA.
. Manage labeling projects in support of new R&D product and
product modifications.
. Organize and track each task and ensure labeling assistant to
process next step.
May 2005 - August 2012 Abbott Vascular Temecula, CA
Regulatory Affairs/ Package Labeling
Int. Sr. Associate, Labeling
. Working under highly regulated Federal Drug Administration
("FDA") environment in the Regulatory Affairs department.
. Create, route and approve Change Order and Change Request.
. Ensures project team to determine artwork/labeling specifications
according to the nature of the product, cost limitations, legal
requirements, and the type of protection required.
. Creating labels for vascular products and managing documents
according to FDA regulation in the company's documentation
database application.
. Training engineers in the processes and procedures of labeling.
. Providing upper level management with the labeling resources
required to prepare for new product launches, including help in
planning for FDA approval.
. Developing procedures to improve printing labels on the
manufacturing line.
. Supporting quality and manufacturing engineers with implementing
new labeling part numbers both on paper and in the company's
documentation database application.
. Creating and revising Instructions for Use and documents.
. Communicating and meeting with vendors and customers to improve
packaging material and planning new implementation of packaging
materials, including Instructions for Use and labeling cartons.
. Planning the labeling deliverables throughout the department for
any changes, as well as working with the labeling supervisor to
provide timelines on deliverables to internal customers.
. Revising procedures, including Standard Operating Procedures
("SOP") & Detailed Operating Procedures ("DOP") according to new
regulations from FDA and our international notified body.
. Testing of labeling system software, as well as troubleshooting
the software, and working to optimize the system for all users.
. Prepare and program the electronic Instruction for Use (IFU) for
corporate web site.
. Organize and manage the new product project as a label designer.
Nov. 2003 - April 2004 Audible.com Wayne, NJ
Art Director
. Produce and design the banner for corp. web site and affiliate
site
. Prepare the graphic elements for corporate web site.
. Create print ad, brochure and advertising materials for publishing
industry.
. Design on-line promotions, bookcovers, contents and user
interface.
Dec. 2002 - July 2003 Colt ne/Whaledent Inc.
Mahwah, NJ
Sr. Designer / Document specialist
. Produced and design the print Ads for magazine, web, and
newspaper.
. Updated the graphic elements in corporate web site.
. Created annual reports, brochure and advertising material for
dental industry.
. Colt ne/Whaledent is a world wide multi-million dollar dental
device and equipment manufacturer.
. Assisted in coordinating and ensuring communication between
departments to ensure a quality project was delivered.
. Implemented new web-related technologies and update the computers.
. Planed, installed and configure for backups, S/W and operating
system.
Sep. 2002 - Nov. 2002 Samsung Electronics (Cheil
Communication Inc.) Ridgefield, NJ
Freelance Graphic Designer
. Produced and designed the print Ads for magazine, billboard, and
newspaper. Major clients are Samsung Electronics, Microsoft, 3M,
and Adidas.
. Determined size and arrangement of illustrative material and copy,
selected style and size of type, and arranged layout based upon
available space, knowledge of layout principles, and aesthetic
design concepts.
July 2000 - March 2002 BRAND24 New York, NY.
Jr. Art Director
. Produced print ads, brochure and annual reports from conceptual
stage to final production utilizing Adobe S/W for element design
and Quark for layout design.
. Involved in determining advertising and marketing needs for
clients through participating in team strategies.
. Assisted in creating commercial web sites and database design for
company products including updating products, inventory, and
shopping carts.
. Maintained and provided ongoing design of websites, promos and ad
banners, and seasonal content specials, as well as implemented
HTML modifications.
. Photographing products for web preparation operating with digital
camera.
TECHNICAL PROFICIENCIES
Graphics: QuarkXpres, Adobe Creative Suite Pro CS6
Labeling: LCS, SymArt Pro, Easy Label, Loftware, Barcode Pro and
Bartender
Web: Flash MX, HTML, DHTML, JavaScript, Dreamweaver MX, BBEdit
6, and Acrobat 9
Office: Microsoft Office 2007, ViewPoint, Oracle JD Edwards
System: Unix, Mac, And Windows
Quality Skills: Certified CAPA for Initiator, Investigator and
Resolution Planner
EDUCATION
School of Visual Arts, New York, NY
Fall 2000 - Spring 2002
MFA, Computer Arts
School of Visual Arts, New York, NY
Fall 1993 - Spring 1997
BFA, Advertising
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