Principal Labeling Engineer

• Feb 2022 - Present

Senior Product Labeling Specialist

• Apr 2017 - Feb 2022

Responsible for the maintenance of regulatory compliant, competitive , and up- to date all customer facing labeling documents for diagnostics products throughout the product lifecycle in accordance with Sciex policies and procedures. -Serve as labeling process owner from Regulatory Compliance perspective. - Evaluate the impact of new regulations/standards, ensuring their implementation, as well as the integration of labeling for new products. - Develop SOPs (Standard Operating Procedures) for labeling, UDI and GUDID in compliance with all key internal and external global regulatory requirements including EU In Vitro Diagnostic Regulation (IVDR) , GHS and CLP. - Manage any update or change to global labeling standards/procedures and process improvements, routing and approval of assigned labeling deliverables through internal change notice system (3DEXPERIENCE). - Create, update, and maintain graphic design and templates using BarTender® software. - Manage relationships with relevant internal and external resources (e.g., supply chain, legal, clinical, R&D, Tech Publications, QA, etc) to ensure product labeling and production needs are met. - Lead cross- functional collaboration to ensure global labeling requirements are met for new and sustaining products. - Manage review and approval process for labeling content - Lead regulatory / language translation implementation projects for labeling Show less

LABELING / ECO COORDINATOR

• Nov 2015 - Nov 2017

LABELING PROJECT COORDINATOR, MEDTRONIC, MANSFIELD, MA 2015 –2016 • Responsible for coordination of all labeling deliverables, including IFUs (depending on project and plant), patient guides, labels, carton and pouch artwork. • Assess the scope of each project and work with team members and project management to create labeling plans and secure necessary resources. • Manage and coordinate creation/revision of deliverables from project initiation through completion. • Work collaboratively with Regulatory, Legal, Graphic Designers, Package Engineering, Quality Assurance, and Materials Management to meet project deliverables to ensure an uninterrupted product supply. • Provide support for regulatory inspections. • Recommended improvements and developed systems to enhance labeling operations based on innovative approaches to existing processes such as an artwork numbering system, peer review documents and artwork request forms. Show less

MEDICAL DEVICE UDI PROJECT, ARTWORK / ECO COORDINATOR

• Nov 2014 - Nov 2015

MEDICAL DEVICE UDI PROJECT, MEDTRONIC, MANSFIELD, MA 2014 – 2015 ARTWORK / ECO COORDINATOR • Responsible for the medical device label artwork project coordination of graphic design development and approval, including project definition, artwork development, translation and label copy review. • Write complex ECOs cover and title pages following the ECO procedure • Communicate with plant engineers and label artwork approvers to ensure completeness and accuracy of ECO documentation • Proactively research, review and/or check ECOs for discrepancies against information provided in ECOs. Consult with department lead and Change Order Requesters (Plants) to resolve discrepancies and issues • Coordinate with Regulatory Affairs regarding questions and concerns on Artwork routing for approval • Maintain internal labeling spreadsheets and tracking systems • Follow standard guidelines and documented procedures for master branding, technical labeling, and regulatory requirements in the creation of technical documents Show less

Marketing Coordinator

• Jan 2011 - Jan 2014

Independently created and designed marketing strategies for local, small business with a 70% increase in annual profits over past 2 years. Manage and oversee online advertising on e-commerce sites including listings on cars.com and autotrader.com. * Focused marketing efforts on generating repeat customer base, customer referrals, and excellent customer service. • Increased company revenue by 60% and reduced advertising costs by $2,000/month in 2013. Independently created and designed marketing strategies for local, small business with a 70% increase in annual profits over past 2 years. Manage and oversee online advertising on e-commerce sites including listings on cars.com and autotrader.com. * Focused marketing efforts on generating repeat customer base, customer referrals, and excellent customer service. • Increased company revenue by 60% and reduced advertising costs by $2,000/month in 2013.

Marketing Member-Board of Directors

• May 2008 - 2014

Served in a voluntary leadership capacity for non-profit banking organization servicing Lithuanian-American community. • Increased membership by 15% in 2013. • Oversaw the marketing plan for organization and created promotional materials translated in English, and Lithuanian. Wrote quarterly newsletters. Designed customer satisfaction surveys, evaluated responses, and generated reports. • Key role in improving online, web presence. Served in a voluntary leadership capacity for non-profit banking organization servicing Lithuanian-American community. • Increased membership by 15% in 2013. • Oversaw the marketing plan for organization and created promotional materials translated in English, and Lithuanian. Wrote quarterly newsletters. Designed customer satisfaction surveys, evaluated responses, and generated reports. • Key role in improving online, web presence.

Marketing Consultant

• Jan 2008 - Jan 2009

Hired as an Independent Contractor for New England based technology company, which is focused on providing personal technology software solutions. • Utilized effective communication strategies with Marketing Operations Manager to ensure accurate lead processing, follow up, and database management using Salesforce.com Hired as an Independent Contractor for New England based technology company, which is focused on providing personal technology software solutions. • Utilized effective communication strategies with Marketing Operations Manager to ensure accurate lead processing, follow up, and database management using Salesforce.com

Marketing Specialist

• Jan 2006 - Jan 2007

Assumed lead role in maintaining company presence at nation-wide trade shows and conferences. • Generated promotional and marketing materials for products. • Gained crucial experience writing promotional materials, online publications, product marketing, and market research. • Organized, updated, and maintained accurate CRM, customer, prospect, research, and marketing databases. • Assisted with company and product launches. Assumed lead role in maintaining company presence at nation-wide trade shows and conferences. • Generated promotional and marketing materials for products. • Gained crucial experience writing promotional materials, online publications, product marketing, and market research. • Organized, updated, and maintained accurate CRM, customer, prospect, research, and marketing databases. • Assisted with company and product launches.