1+ months

Business Analyst, Project Lead -- Labeling & UDI

Plymouth, MN

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

We are seeking an experienced, high caliber Analyst II  -- Labeling & UDI Systems  who will be responsible for implementing and maintaining the effectiveness of Quality System (QS) and Production applications supporting Labeling and Unique Device Identifier (UDI).  Analyst II will provide support for medium and large systems projects and initiatives.

Impact this role will have on Abbott

  • Leads and drives cross functional activities associated with medium and large projects or initiatives with a labeling and/or UDI impact.
  • Employs sound project management methodologies to deliver projects with concurrent deadlines.
  • Provides in depth knowledge of US and worldwide labeling and UDI regulations.
  • Evaluates and monitors business processes and applications for effectiveness.
  • Correlates data and utilizes sound analysis skills to determine team capacity and imitations.
  • Analyzes business results, discrepancies, and delivers robust corrective and preventative solutions.
  • Communicates complex concepts in a manner understood by broad audiences.
  • Monitors for new developments in technologies that benefit labeling and/or UDI.
  • Represents user needs and requirements, assists with user application testing (UAT), and verification activities for system changes that impact labeling and/or UDI.
  • Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

    Your Experience (s), education and knowledge will further expand Abbott’s marketplace success:

    • Requires a Bachelor’s degree and a minimum of 2 to 4 years’ experience working with product labeling, quality systems and/or regulatory.
    • Proven ability to learn new software applications quickly.
    • Experience in Product Data Management (PDM), Manufacturing Execution System (MES), Enterprise Resource Planning (ERP), or SAP systems preferred.
    • Experience in Medical Device and/or a regulated environment preferred.
    • Advanced MS Excel skills and experience with other MS Office Software (MS Word, PowerPoint, MS Project).
    • Ability to work in a highly matrixed, fast-paced and geographically diverse business environment.
    • Ability to leverage and/or engage others to accomplish projects.
    • Excellent verbal and written communications with ability to effectively communicate at multiple levels in the organization.
    • Proven ability to multitask, prioritize and meet deadlines.
    • Exceptional organizational and follow-up skills, and attention to detail.
    • Ability to travel approximately 15%, including internationally.
      Job Family: Regulatory Operations
      Division: CAHF Cardiac Arrhythmias & Heart Failure
      Travel: Yes, 5 % of the Time
      Medical Surveillance: No
      Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)


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Business Analyst, Project Lead -- Labeling & UDI

Plymouth, MN

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Plymouth, MN

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