Lindsey Goller

Key liason representing Labeling CoE for New Product Development teams across 4 franchises, interfacing with stakeholders to capture requirements, develop and manage labeling development project plans/timelines in alignment with overall NPD Project schedules. Accountable for supervising labeling designers to align labeling timelines with the NPD team product launches. Lead and support CAPAs and NC’s as required.

• Partner with global and local Regulatory, Manufacturing, Legal, R&D and Quality teams to remediate data gaps or issues. Prepare, hold and lead cross-functional meetings
• Contribute to continuous improvement of the end-to-end labeling process
• Provide proactive support during preparation and review of project information and job inputs
• Collaborate with cross‐functional partners to develop labeling concept design
• Coordinate review of documents and follows up to resolve issues in the interest of keeping the project streamlined and moving forward
• Attend Project Team meetings (Strategy, Scope & Implementation)
• Provide guidance to business partners on labeling approval process
• Track timelines and objectives of labeling activities across all franchises
• Work within a validated electronic system to coordinate labeling submission routing, review & approvals
• Recommend process improvements as appropriate

Responsible for designing all labeling for the Mitek Sports Medicine franchise. An emphasis is placed on compliance, innovation, document management and version control. I interacted with technical experts, product managers, international manufacturing sites and regulatory management to assure that all Mitek labeling is maintained and accessible, and submission needs are met in a timely and efficient manner.

• Developed new product labeling, attain approval, and ensure implementation and production needs and requirements are met. Prepared printed components and related support documentation for regulatory submissions.
• Engaged with business stakeholders to create and execute project timelines.
• Managed internal documentation requirements including change controls, specifications, item code creations and artwork libraries. Maintained management of corporate branding, color and font standards.
• Supported internal regulatory audits to provide proper access to documentation and records.
• Developed improvements to internal processes and procedures by supporting the use of current tools, and technologies to support efficient global label development.
• Served as the primary information base for all issues related to product labeling/printed components. Monitored overall artwork management process and implement continuous improvement approach.
• Ensured labeling is in compliance with Quality system requirements, applicable domestic, international regulatory requirements and assisted Quality counterparts with investigation activities, where labeling was involved.
• Designed labels that met business and industry regulations, including EN 980 and ISO 15223 Medical Device symbols. Determined symbology requirements to meet FDA and BSI regulations and packaging requirements, and worked directly with packaging to develop new label stock to meet NPD business needs.

Lead Graphic Designer
Covidien, Respiratory & Monitoring Solutions Franchise
Boulder, Colorado

Lead the Artwork design team for the Respiratory & Monitoring Solutions business unit. Supervised a team of labeling and packaging designers to provide artwork to meet project timelines.
• Created and designed Unique Device Identification (UDI) specific design guidelines for project teams
• Developed Corporate design guidelines to support UDI project for team of designers
• Designed and implemented proof-reading procedures for designers to ensure Quality and FDA regulations were met
• Attended Project Team meetings (Strategy, Scope & Implementation)
• Followed Agile CDP regulations to coordinate labeling submission routing, review & approvals
• Collaborated with global manufacturing plants, engineers and data management teams
• Liason to global Manufacturing facilities to integrate GS1 barcode verification process
• Tracked timelines and objectives of design activities

Responsible for managing branding processes and was the liaison for all global branding and design needs, specific to the Medical Supplies business unit. Designed product artwork for the Medical Supplies Franchise based on FDA regulations, including UDI requirements, for all existing products and new acquisitions.

• Designed and implemented artwork based on FDA and regulatory requirements
• Created packaging templates and executions to adhere to Covidien design guidelines
• Attended Project Team meetings
• Collaborated with global manufacturing plants, in-house engineers, regulatory personnel and data management teams
• Followed Agile CDP regulations to process labeling submission routing, review & approvals
• Designed new product artwork, corporate collateral and global marketing material for internal distribution
• Developed PowerPoint presentations, brochures, diagrams, e-blasts, brand templates and posters
• Retouched, organized and documented product catalogs and internal corporate photography
• Collaborated with colleagues to create a new brand strategy and corporate design guidelines on a global scale
• Developed collaborative relationships with teams from manufacturing, regulatory, product marketing managers, engineers and outside vendors to ensure corporate guidelines and production qualifications were met