Labeling Project Manager

Job DescriptionWorking at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and 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 high employer contribution.Tuition reimbursement, the student debt program and 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.The OpportunityThis position works out of our Plymouth, MN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.The Labeling Project Manager will be responsible for meeting business needs by supporting the Labeling and Universal Addendum Labeling (UAL) teams by leading/implementing projects, conducting analysis, developing managing master data, communicating with cross functional teams, and problem-solving various challenges. Top candidates will have demonstrated skills in utilizing program management methodologies, excellent organizational and problem-solving abilities, and exceptional communication skills.What you'll work onDevelop, communicate, and drive detailed schedules and timelines for program deliverables across multiple organizational functions.Create and manage labeling and UAL change processes within the document management systems.Work cross-functionally to identify and resolve labeling and UAL inconsistencies to meet applicable requirements and project timelines.Monitor for program risks and issues, and drive for resolution.Ensure cross functional alignment on objectives and tasks.Manage Labeling and UAL 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 regulations and cross-functional business requirements.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.QualificationsBA or BS degree in Business, Engineering, Supply Chain Management and/or Logistics, or Operations Management or equivalent combination of education and work experience.Project management certifications preferred. Minimum 5 years medical device industry experience preferred.2+ years of successfully leading large-scale, multi-functional programs preferred.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 a leader in a fast-paced, changing environment.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.Database management and/or analytics software knowledge preferred.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.The base pay for this position is $60,000.00 – $120,000.00 In specific locations, the pay range may vary from the range posted.Job Family: Regulatory OperationsDivision: SH Structural HeartLocation: United States > Minnesota > Plymouth : 5050 Nathan Lane NAdditional Locations:Work Shift: StandardTravel: NoMedical Surveillance: Not ApplicableSignificant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.