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Available for Employment Opportunities

As a Senior Medical/Pharma Labeling and Packaging Specialist, 
with advanced experience at all levels of the production processes, 
it is with great interest that I am presenting my résumé, in consideration 
for ANY employment opportunities.
 
Notable accomplishments:
 
-  	Key Graphic Designer to Directors, Project Managers and Stakeholders for: 
Philips, Abbott, Edwards, Baxter, Sun Country Airlines, IBM, Cargill, 3M, RBC, 
Wells Fargo, Ford, Jaguar, YWCA, Saks Fifth Avenue, Mercedes Benz, US Bank, 
GM, Best Buy, Lexus, Mayo Clinic, BMW, Betty Ford Foundation, Porsche, 
Volkswagen, Ben & Jerry's, Chrysler,  Jaguar, Ben & Jerry's, GM, PGA, 
Select Comfort, Best Buy, Marriott, Aveda, Thomson Reuters, 
Macy’s, St. Jude Medical

-  	Generated and Managed 10,000+ global and country-specific labels, 
	and production procedures to ensure regulatory, quality, and commercial compliance

-  	Updated 5,000+ labeling artwork files that meet all new UDI, EU MDR regulations

- 	Proactively released new products, while maintaining FDA, ISO, GS1, and other 
	global compliances  
 
- 	Primary Administrator for planning and development of graphic projects, 
completed with precision. Working with writers, and ensure objectives are 
illustrators, photographers, designers, developers 	
	
-   	Spearheaded idea generation, concept development, and visualization, 
design inputs, brand guidelines, for creation and approval of artwork, including, 
all forms of print production, logos, packaging, retail displays, and visual production

My deep knowledge is in core label design, package creation, and concept 
direction, with deep insights in requirements, guidelines, instructions, 
templates, and procedures that are in accordance with international labeling 
rules and regulations.

I’m available for employment immediately and will relocate to the location of employment. 

I invite you to contact me for a personal interview where we can discuss the value I 
would bring to you.

I look forward to hearing from you, and to becoming part of your talented team.


•	Using deep knowledge of global compliance, technical and graphic design expertise, to lead in the 	creation and maintenance of labeling artwork design for Philips Respironics’ Global Product Labeling
•	Systematically review, create, and update all labeling design elements, including but not limited to:
o	Product identification 
o	International regulatory and compliance requirements
o	Sales appeal/aesthetic quality
o	Printing and production techniques at the highest level technical discussions 
o	Technical Reviews held at key decision points
o	Create/redesign symbols adhering to the harmonized global symbology:
	(FDA, EU/MDR, ISO, NMPA, RZN, MFDS, etc. regulations) 
o	Contact information for global manufacturing, assembly, distribution
o	Barcode placement, and barcode compliance. Including UDI, EAN/UPC, 
	GS1 Data Matrix, GS1-128, GS1 DataBar, and GS1 QR Codes
o	Product family, product modifier  
o	Refine layout landscape to be flexible for additional updates and regulations:
	icons, exp. date, assembled by, etc.
o	Handling, distribution, and shipping instructions
o	Storage (i.e. temperature, humidity, drop height requirements)
o	Instructions for Use (IFU)
o	Precautions and warnings
o	Product component labels, including accessories, batteries, etc.
o	Training materials for customers and Clinical Applications Specialists (where applicable)
o	Product datasheets
o	Marketing materials and product claims
o	Service Manuals
•	Conduct Technical Reviews early in the development process, optimizing the design,
	by challenging and evaluating alternatives, to improve product quality by driving out mistakes
•	RGB, CMYK, PAL, Pantone Colorist
•	Labeling Gap Assessments
•	Establish, and introduce new products into corporate labeling, and related Standard Operating 	Procedures (SOP)
•	Focus on business problem identification in conjunction with technical solution paths. 
•	Assist with customer implementation of labeling best practices, train/mentor staff, and engage with technical experts to support their labeling process objectives


LABELING SPECIALIST CONSULTANT III - SYSTEMS ENGINEERING 

•	Create and modify labeling for product labels, cartons, and other related materials ensuring that they 	meet all medical, legal and regulatory requirements for medical devices following the established 	design format, labeling style guidelines and branding guidelines
•	  Functional/core team representative on a cross-functional team in taking labeling content and 	translating it into functional label layouts utilizing labeling software 
•	  Provides direction on label content and process requirements to cross-functional members. 
•	  Major contributor for strategic labeling sub-teams (e.g.: global labeling requirement changes, 	proofreading, tasking, hardware/software solutions, etc.) 
•	  Designs both commercialized and new product labeling projects
•	  Works cross-functionally to drive consistency across labeling project materials, designs and application of requirements to meet project objectives
•	  Product labeling considering such factors as product identification, worldwide requirements, sales 	appeal, aesthetic quality, printing, and production techniques


GLOBAL MEDICAL DEVICE LABELING SPECIALIST 

Design Department leader, during division transition to a fully functioning Asian operation
•	Compile and analyze financial information from different international resources, and 				databases, into graphics and documents adhering to international formats
•	Edit and update SOPs, Daily, Weekly, Monthly and Annual Fund, Annuities, and Investment Reports
•	Create monthly/annual reports, single-sheet handout records, close/terminate records, chart graphics. 
•	Migrated documents final from Development, to Content Writers, QA, Legal, and Publishers 


GLOBAL DOCUMENT PRODUCER: VISUAL/GRAPHIC DESIGNER

•	Responsible for the maintenance of regulatory compliant and up-to-date core labeling documents 
	for assigned markets, throughout product lifecycles, in accordance with Global policies and procedures.
•	Work in close collaboration with Marketing, Quality, Regulatory, Operations, and Development Groups to
	ensure that core labeling documents are aligned with the company’s position on the product’s profile,
	in accordance with international labeling rules and regulations. Provide strategic regulatory labeling input.

ACCOMPLISHMENTS:
	
•	Lead Resource in the preparation of all core labeling, IFU, Guides, E-Learning, and updates for all products.
•	Take the design process from initial concept through preparing files for printing and production
•	Coordinates and manages technical document foreign language translations.
•	Maintain Regulatory Compliance, which observes US and International Labeling rules and regulations
•	Ensure labels are satisfied to Global Regulatory, Legal, Clinical, R&D, Engineering, Manufacturing and 
	Marketing requirements. Including FDA, EU/EMA, UDI, GHS, ISO, GS1, MDR and compliance regulators
•	Contribute to the creation of documents supporting changes to the labeling documents with internal 
	and/or external experts, including the preparation of responses to labeling-related queries
•	Present and defend proposed changes to global core labeling documents, including copywriting
	labeling documents in key markets, for review and audits 
•	Establish that key country label proposals that deviate from Country's (e.g. EU, US) Regulations are brought 
	to the attention of the Regulatory Affairs and Management Groups, together with rationale. 
•	Ensure compliance with all relevant regulatory, legal, and Quality Management Systems’ requirements



PROJECT MANAGER OF LABELING/PACKAGING AND COMPLIANCE 

On-site Medical Device Labeling Development Expert, for the Graphic Design, Production and Implementation of Global UDI (Unique Device Identification) readiness, and to make the necessary adjustments to achieve compliance across their enterprise and be prepared for ensuing phases of the new International regulations

ACCOMPLISHMENTS:

•	Design Product Labels, Packaging, Shipping Identification, Operator Manuals, Instructions For Use, 		Direction Inserts, Patient Guides, and Procedures, for FDA submission, and Audits.
•	Preparations of graphics for new products and product changes as required
•	Guarantee timely approval for market release, in accordance with Global Laws and Governing Boards.
•	Guidance and review of product labeling, change control and other related product documentation.
•	Maintain regulatory affairs product files to support compliance with requirements and standards.



LEAD UDI GRAPHICS/LABELING DESIGNER AND DEVELOPMENT 

Develop and execute essential core product labeling for device identification, traceability to set the direction for
a consistent look and feel to maximize brand manifestation. Methodize QMS, PDP, ERP, and PLM databases.
					
ACCOMPLISHMENTS:
	
•	Create and standardize digital, on-line production, and pre-printed labeling solutions for medical devices
	Including product labels, Tyvek packaging, trays, sleeves, inserts, kits, and related materials 
•	Ensure labels are satisfied to Global Regulatory, Legal, Clinical, R&D, Engineering, Manufacturing and 
	Marketing requirements. (FDA, EU/EMA, UDI, GHS, ISO, GS1, MDR and from compliance regulators)
•	Perform Content Creation and Audits, Redlining, Proofing, BOM/Router changes and Approval of artwork 
•	Participate in strategic team meetings to align business objectives, priorities, risks, and process improvement 
•	Participate in labeling strategy, to modularize content, emphasizing symbols to maximize label real estate
•	Determine symbology graphics for International requirements, to ensure global approval and implementation


MEDICAL DEVICE GLOBAL GRAPHICS/LABELING SPECIALIST 

Lead in integrating new global enterprise label software system. Design, test, and document business essentials Create guidelines, instructions, and procedures that support development and implementation

ACCOMPLISHMENTS:

•	Global Labeling Design through standardization and reliable identification of 3M products
•	International Consultant of label printing through hardware configuration 
•	Enhanced brand awareness, brand equity, providing stronger global 3M presence
•	International Security Access: Permissions/Rules/Roles/Users/Groups

ADDITIONAL AUTHORITY:

•	Deployment Coach				•     Coordination of Label Template/UI promotion
•	Confirmation of Templates and Data		•     Perform User Acceptance Tests and Publish Results
•	Quality Assurance Testing 			•     Site User Acceptance and Software Testing 	
•	Label Rationalization (Future Requirements)	•     Current and Future State Labeling Footprint Map 



INTERNATIONAL LABELING I.T. ANALYST III 

•	Key Graphic Designer to Directors, Project Managers and Stakeholders for: 
Philips, Abbott, 	Edwards, Baxter, Sun Country Airlines, Medtronic, IBM, Cargill, 
3M, RBC, Wells Fargo, Ford, YWCA, Select Comfort, Saks Fifth Avenue, 
Mercedes Benz, US Bank, GM, Best Buy, Lexus, Mayo Clinic, BMW, St. Jude Medical, 
Betty Ford Foundation, Porsche, Volkswagen, Ben & Jerry's, Chrysler, Jaguar, 
Ben & Jerry's, PGA, Marriott, Aveda, Thomson Reuters, Macy’s, Thomson Reuters, St. Jude Medical
•	3,500+ designs gone to press and 20,000,000+ images are produced annually.
•	Lead graphics coordinator involved in the design and process involving marketing, 
communications, packaging, labeling, regulatory, manufacturing 
•	Production of pixel-perfect designs, to be produced, concentrating on print/digital formats  
•	Provide cross-disciplines teams expert instruction in focusing on improvement of design,
 work path, cost reduction, cycle time, and client satisfaction
•	Color Correction, Image Editing,
•	State of Minnesota Adobe Photoshop/Illustrator Instructor

CREATIVE DESIGNER AND DIRECTOR

Find out detailed information about Scott Coran,  in Carlsbad, CA

Scott Coran: in Carlsbad, CA

Scott Coran