At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Plymouth, MN location in the SH divison.

Structural Heart Business Mission: Why We Exist.

Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

The Labeling Business Analyst II will be responsible for supporting strategies which ensure compliance and meet business needs. This role will support the Labeling, Universal Addendum Labeling (UAL), and Unique Device Identification (UDI) teams by conducting analysis, managing master data, leading projects, communicating with cross-functional teams, and problem-solving various system and process challenges.

What You’ll Work On

• Acquire data from primary and secondary data sources and maintain databases. Analyze and interpret data sets and identify methods of resolution.
• Manages concurrent deadlines and meets deadlines for assigned work/tasks. Plan, lead, and implement projects of varying size.
• Assess compliance to world-wide UDI regulations and cross-functional business requirements.
• Track and report on performance metrics, measuring results against critical success factors.
• Manage Labeling and UDI master data and workflow via internal IT systems. Execute test protocols, maintain or create departmental work instructions, facilitate end-user training and assists in identifying resolutions business and technical problems.
• Collaborate with internal & external customers, contractors, and vendors to ensure user requirements are complete confirming changes and enhancements meet technical specifications and user requirements.
• Research technology trends and new developments in order to identify efficient methods of accomplishing business and information systems goals.
• 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.

Required Qualifications

• BA or BS degree in technical discipline preferred, or equivalent combination of education and work experience.
• 3 – 5 years’ technical experience in a medical device industry and/or multi-division business unit 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.
• 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, or other analytics and database management software.
• Knowledge of FDA & EU regulations, GS1 and ISO standards.
• Ability to manage projects and drive them to completion.
• 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.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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