Labeling Project Manager – On-site (Plymouth, MN)
Job Summary
Abbott’s Structural Heart Division is hiring a Labeling Project Manager to join its regulatory team in Plymouth, Minnesota. In this role, you will lead and implement labeling and universal addendum labeling (UAL) projects, manage master data, ensure regulatory compliance, and drive process improvements. This is an excellent opportunity for experienced professionals in regulatory affairs or medical device labeling to contribute to life-saving cardiovascular innovations.
Key Responsibilities
Develop and manage detailed schedules and timelines for labeling and UAL deliverables.
Lead labeling and UAL change processes using document management systems.
Collaborate cross-functionally to identify and resolve labeling inconsistencies.
Monitor program risks and drive timely resolutions.
Maintain Labeling and UAL master data workflows via internal IT systems.
Analyze large datasets and recommend resolutions to process challenges.
Ensure compliance with global labeling regulations and business requirements.
Support company Quality Management Systems (QMS) and Environmental Management Systems (EMS).
Communicate effectively across teams to drive project success.
Required Skills & Qualifications
Bachelor’s Degree in Business, Engineering, Supply Chain, Logistics, or related field.
Project management certifications preferred.
Minimum 5 years of experience in the medical device industry preferred.
2+ years of successfully managing large-scale, multi-functional programs preferred.
Strong problem-solving and organizational abilities.
Knowledge of FDA, EU regulations, GS1, and ISO standards.
Experience with ERP/PLM systems (SAP, Windchill preferred).
Proficient in Microsoft Excel, PowerPoint, Word, Access.
Strong analytical skills with database management or analytics software knowledge preferred.
Perks & Benefits
Salary Range: $60,000 – $120,000 annually.
Free medical coverage under HIP PPO (eligibility dependent).
Excellent 401(k) retirement plan with high employer contribution.
Tuition reimbursement & Freedom 2 Save student debt program.
FreeU education benefit supporting affordable degree completion.
Career development in a globally recognized healthcare company.
Company Description
Abbott is a global healthcare leader providing cutting-edge solutions in medical devices, diagnostics, nutrition, and branded pharmaceuticals. With operations in 160+ countries, Abbott enhances lives through technology and innovation in healthcare.
Work Mode
On-site – Plymouth, Minnesota, United States
Call to Action
Advance your career with Abbott’s Structural Heart Division! Apply now to lead impactful labeling projects and shape the future of cardiovascular healthcare technologies.
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