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I'm Amber Okwuosah, a packaging and labeling specialist with over 16 years of experience supporting regulatory labeling and compliance for biologics, pharmaceuticals and medical devices. I partner with cross-functional teams to develop patient-focused packaging & labeling that aligns with strategies and regulatory requirements, advance labeling compliance and operational excellence in pharma and medical devices.…I'm Amber Okwuosah, a packaging and labeling specialist with over 16 years of experience supporting regulatory labeling and compliance for biologics, pharmaceuticals and medical devices. I partner with cross-functional teams to develop patient-focused packaging & labeling that aligns with strategies and regulatory requirements, advance labeling compliance and operational excellence in pharma and medical devices.

Amber Okwuosah

Graphic Designer, Designer, Brand Designer, +2

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I'm Amber Okwuosah, a packaging and labeling specialist with over 16 years of experience supporting regulatory labeling and compliance for biologics, pharmaceuticals and medical devices. I partner with cross-functional teams to develop patient-focused packaging & labeling that aligns with strategies and regulatory requirements, advance labeling compliance and operational excellence in pharma and medical devices.…I'm Amber Okwuosah, a packaging and labeling specialist with over 16 years of experience supporting regulatory labeling and compliance for biologics, pharmaceuticals and medical devices. I partner with cross-functional teams to develop patient-focused packaging & labeling that aligns with strategies and regulatory requirements, advance labeling compliance and operational excellence in pharma and medical devices.

Available to hire

I’m Amber Okwuosah, a packaging and labeling specialist with over 16 years of experience supporting regulatory labeling and compliance for biologics, pharmaceuticals and medical devices. I partner with cross-functional teams to develop patient-focused packaging & labeling that aligns with strategies and regulatory requirements, advance labeling compliance and operational excellence in pharma and medical devices.

Skills

Experience Level

Expert

Expert

Expert

Expert

Intermediate

Intermediate

Language

English

Fluent

Work Experience

Project & Customer Support Specialist at Innovatum Incorporated

September 9, 2020 - August 15, 2024

Assisted medical device & pharmaceutical clients with software transition planning and execution. Parsed and restructured data for integration into Robar database. Designed carton, kit, and instructional device labeling to meet regulatory requirements, industry standards, and customer specifications. Supported labeling change management, regulatory compliance, and pre-launch testing. Trained customer label designers on Robar database functionality and Bartender formatting.

Labeling Project Manager – Consultant at Bear Creek Consulting

June 1, 2023 - December 31, 2023

Evaluated customer regulatory labeling template library and databases. Developed and executed strategy for CAPA-related labeling processes. Consolidated database management and updated security groups for compliance with EU MDR & global device labeling requirements. Revised label department documentation for quality and compliance prior to implementation.

Label Development Technician II – Quality at Wright Medical Technology

March 10, 2010 - July 17, 2015

Supported labeling for new biologics, extremities, and large joint product launches. Designed compliant, brand-standard labels per FDA, ISO, EU, and device traceability requirements. Managed end-to-end conversion of global catalog database to new software platform. Managed business unit rebranding design project for new carton and labeling designs & manage dual systems. Oversaw labeling CAPA assignments, barcode configuration, and Operations printer troubleshooting. Authored and revised departmental SOPs to improve labeling processes.

Label Development Technician II – Packaging Engineering at Wright Medical Technology

January 1, 2007 - January 1, 2009

Designed and executed packaging labeling to meet regulatory and brand standards, contributing to global labeling initiatives and packaging design

Regulatory Affairs Technician I – Clinical & Regulatory Affairs at Wright Medical Technology

January 1, 2006 - January 1, 2007

Supported regulatory labeling initiatives for clinical and regulatory affairs. Key contributions included designing compliant labels, managing catalog/database transitions, and supporting CAPA-related activities.

Associate Lab Technician at Kraft Food Ingredients

December 30, 2000 - December 30, 2005

Conducted rheological analysis on soft cheese and confectionary products. Calibrated and maintained laboratory equipment including rheometers, pH meters, and balances. Maintained laboratory notebooks and project databases.