Document Specialist - Medical Device Labeling Expert

PROFESSIONAL SUMMARY

Concept-driven Senior Graphic Designer and Studio Director with over 25 years’ experience partnering with brands and manufacturers across diverse industries, including biomedical, food, pharmaceutical, and consumer products, translating strategic ideas into production-ready artwork, packaging, and brand identity. I combine art direction, image creation, and core label design/production workflow expertise with proven U.S. and Global project management to turn complex requirements, templates, and regulatory procedures into on brand, audit ready deliverables that meet regulatory standards. As a seasoned medical device labeling and illustration specialist, I have led end-to-end labeling strategy and regulated user information for world markets, covering UDI/GS1 implementation, FDA and EU/MDR submissions, labeling lifecycle management, human factors/usability integration, and ISO 14971 risk mitigation, and I build cross-functional governance, SOPs, and change control to improve printability, manufacturability, compliance, and reduce labeling risk for enterprise programs

PROFICIENCY HIGHLIGHTS

CORE COMPETENCIES

Regulatory labeling, Labeling governance, UDI strategy, GS1 DataMatrix, GS1-128, EAN/UPC, QR, Barcode symbology, IFU/Instructions for Use, User information, Digital Asset Management, Packaging design, Artwork production, Printability, Color management (CMYK/RGB/Pantone), Prepress, Technical publications, Illustration & iconography, Harmonized symbols, Human factors engineering, Usability testing, Risk management (ISO 149 71), FDA 21 CFR, EU MDR 2017/745, ISO 13485, NMPA, MFDS, Label lifecycle management, Change control, SOP development, Design History File (DHF), Regulatory submissions (510(k)/Technical File), CAPA, Cross-functional leadership, Mentoring, including controlled documents

SELECTED SOFTWARE & SYSTEMS

Adobe Acrobat Pro Adobe Illustrator Adobe Photoshop

Adobe InDesign MS Windows 365 Suite SharePoint

Authenticator Workday Label management systems

SAP Monday.com PLM integrations; Authentication tools

PROFESSIONAL EXPERIENCE

SENIOR INFORMATION DESIGNER/ LABEL DESIGN DEVELOPMENT/TECHNICAL SPECIALIST II

BECTON DICKINSON BIOSCIENCES – San Jose, California November 2019 – January 2026

- Led global labeling strategy and governance for clinical reagents and devices across the US, EU/MDR, China (NMPA), Korea (MFDS) and other regulated markets; ensured alignment with FDA 21 CFR, ISO 13485 and MDR requirements.

- Owned UDI program design and barcode strategy (GS1 DataMatrix, GS1-128, EAN/UPC, GS1 DataBar, QR)

to enable lot traceability, recall readiness, supply chain traceability, and post-market surveillance.

- Designed and implemented harmonized symbology, iconography, and standardized illustration libraries to improve bedside usability and reduce user error in acute and home-care environments.

- Translated clinical protocols and complex device functions into clear, compliant IFUs, quick-start guides, USB cards and cases, patient materials, and packaging artwork optimized for printability and manufacturability.

- Integrated labeling deliverables in risk management, human factors/usability testing; authored labeling for sterile packaging, expiration date/shelf-life, storage, handling, and lot traceability to protect product integrity.

- Established and maintained SOPs, labeling change-control, and lifecycle management classifications

(RUO, IUO, ASR, IVD, LDT); participated in the labeling review boards and change advisory processes.

PROFESSIONAL EXPERIENCE (cont’d)

- Collaborated cross-functionally with regulatory affairs, quality, R&D, manufacturing, supply chain,

and clinical teams to support regulatory submissions and Design History File (DHF) completeness.

- Mentored and trained multi-disciplinary teams on regulatory labeling requirements, symbology,

and labeling best practices.

- Implemented enterprise templates, reducing labeling errors 90% and accelerating release time by under 6 weeks

- Owner and primary SME for enterprise labeling review sites and project-specific Teams hubs supporting labeling governance and document control.

- Recognized contributor to product and function awards for clinical reagents and R&D contributions: Product Group of the Year and Function of the Year.

- Graphic design SME for Assessment of Change requirements, supporting labeling impact analysis and

regulatory strategy.

- Member of internal AI-dashboard initiative focused on labeling/graphics data integration and automation.

PREVIOUS ROLES

LABELING SPECIALIST CONSULTANT III — SYSTEMS ENGINEERING Feb 2019 – Sep 2019 PHILIPS RESPERONICS — Carlsbad, California

- Conducted labeling system assessments and change-control execution supporting medical device lifecycle and compliance with QSR and ISO controls.

GLOBAL MEDICAL DEVICE LABELING SPECIALIST Apr 2018 – Feb 2019

ABBOTT VASCULAR — Temecula, California

- Managed global label content, UDI integration, and labeling artwork for vascular devices; supported regulatory submissions and labeling risk assessments.

GLOBAL LABELING SME, PROJECT MANAGER, LEAD UDI LABELING DESIGNER 2014 – 2018

BAXTER HEALTHCARE / EDWARDS LIFESCIENCES / BIONESS / 3M / THE CAPITAL GROUP

- Labeling/Packaging & Compliance, Visual/Graphic Producer, International Labeling IT Analyst

- Delivered labeling artwork, prepress, packaging compliance, and labeling IT transformation across multiple medical device product lines and manufacturing sites.

- Implemented labeling process improvements, standardized artwork templates, and drove supplier printability standards and vendor qualification alignment.

OWNER/DIRECTOR January 2000 – Present

CORAN VISUAL INSTITUTE – San Francisco, California - Minneapolis, Minnesota

- Senior studio leader delivering end-to-end art direction for advertising, marketing, promotional, biomedical, food, pharmaceutical, labeling, packaging and consumer products (US & OUS)

- Selected clients include Sun Country Airlines, IBM, Cargill, 3M, RBC, Wells Fargo, Audi, Mercedes Benz, U.S. Bank, GM, Best Buy, The Mayo Clinic, Jaguar, Allina, Thomson Reuters, Ford, Ben & Jerry's, Allina, General Motors, BMW, Chrysler, Mall of America, University of Minnesota, Porsche. • Concept & information design expert: Typography, visual hierarchy, color systems, iconography, harmonized symbology, to create clear, on brand, accessibility driven communications.

- Production ready artwork specialist: die-lines, prepress proofing, color management, PDF/X, imposition, and manufacturable package/label layouts; pragmatic regulatory and lifecycle lead managing vendor qualification, version control, and controlled document workflows to ensure traceability, compliance, faster time to market, and Digital Asset Management.

- Proven program manager of complex, cross functional initiatives—partnering with R&D, regulatory, quality, manufacturing, and supply chain teams; technical fluency with Adobe Creative Suite, MS 365, PLM/SAP, and document control/versioning platforms, focused on audit ready, manufacturable deliverables.

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