Labeling Project Manager

Abbott Laboratories; Plymouth (MN); On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Tuition reimbursement

FreeU education benefit

Health insurance (HIP PPO)

Job summary

Abbott Laboratories in Plymouth, MN is seeking a Labeling Project Manager to lead labeling and UAL initiatives, manage master data, and coordinate cross-functional teams. The role focuses on applying program management methods, data analysis, and strong communication to ensure timely, compliant labeling deliverables.

The position requires a BA/BS in a relevant field and 5+ years in medical devices, with experience in ERP/PLM systems (SAP/Windchill) and knowledge of FDA/EU standards.

Qualifications

• BA/BS in relevant field or equivalent experience.
• 5+ years medical device industry experience preferred.
• 2+ years leading large-scale, multi-functional programs preferred.
• Knowledge of FDA & EU regulations, GS1 and ISO standards.
• Strong written and verbal communication at all organizational levels.
• Experience with ERP/PLM systems, SAP and/or Windchill preferred.
• Proven ability to manage projects with attention to detail.
• Experience with labeling/UDI preferred.
• Proficient in Microsoft Office (Excel, PowerPoint, Word, Access).

Responsibilities

• Develop, 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 requirements and 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.
• Comply with worldwide labeling regulations and cross-functional requirements.
• Support Quality Management Systems, EMS, FDA & worldwide regulations.

Skills

Project management

Analytical skills

Communication

Team leadership

Problem solving

Education

BA/BS in Business/Engineering/Supply Chain/Logistics or Operations management

Tools

SAP

Windchill

ERP/PLM systems

Microsoft Office

Job description

JOB DESCRIPTION

Working at Abbott 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.

• 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 will work out of our Plymouth, MN location. 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 On

• Develop, 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.

Required Qualifications

• BA 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.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is $61,300.00 - $122,700.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality DIVISION: SH Structural Heart LOCATION: United States > Minnesota > Plymouth : 5050 Nathan Lane N ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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