Abbott is a global healthcare leader that helps people live more fully at all stages of life. As a UDI Analyst, you will support the Labeling and UDI teams by conducting analysis, managing master data, and communicating with cross-functional teams to solve various challenges.
Create and manage UDI change processes within the document management systems.
Work cross-functionally to identify and resolve labeling and UDI inconsistencies to meet applicable requirements and project timelines.
Facilitates end-user training and assists in identifying resolution business and technical problems.
Performs analysis and audits of UDI & or Labeling data to support regulatory compliance and cross-functional business requirements.
Manage UDI master data and workflow via internal IT systems.
Manages concurrent deadlines and meets deadlines for assigned work/tasks.
Analyze and interpret large data sets and identify methods of resolution.
Complies to world-wide Labeling and UDI regulations and cross-functional business requirements.
Supports UDI inquiries at internal and external audits.
Trained on and engaged in CAPA activities.
Comply with company initiatives in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), FDA & world-wide regulations, business requirements, company policies and operating procedures.
Qualification
Required
Bachelors Degree in communications, regulatory, business, mathematics or an equivalent combination of education and work experience.
Minimum 1 year related experience
Ability to manage projects and drive them to completion with attention to detail.
Requires ability to be innovative, resourceful, and work with minimal direction.
Knowledge of FDA & EU regulations, GS1 and ISO standards.
Strong written and verbal communication, at all organizational levels.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.
Skilled in Microsoft Office specifically Excel, PowerPoint, Word, and Access.
Preferred
Experience working in medical device industry with focuses on regulatory compliance, quality systems, labeling, or UDI preferred.
Experience working with ERP and/or PLM systems preferred. Preferably SAP and/or Windchill.
Experience utilizing labeling/graphical design software and/or graphical tools such as CAD, Adobe Illustrator/Photoshop or other related software preferred.
Benefits
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
An excellent retirement savings plan with high employer contribution
Tuition reimbursement
The Freedom 2 Save student debt program
FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
Abbott is a healthcare company that is engaged in pharmaceuticals and manufacturing healthcare products.
