Labeling Project Manager – Regulatory Affairs
Location: Plymouth, Minnesota
Company: Abbott
Job Type: Full-Time
Work Mode: On-site
Salary Range: $60,000 – $120,000 (varies by location and experience)
Job Summary
Abbott is hiring a Labeling Project Manager in its Structural Heart division at the Plymouth, MN location. This role is ideal for experienced professionals in medical device labeling, regulatory compliance, and project management. You will manage end-to-end labeling and universal addendum labeling (UAL) processes, ensure alignment with FDA and global regulations, and collaborate cross-functionally to support product quality and patient safety.
Key Responsibilities
Develop and manage detailed project timelines for labeling and UAL deliverables
Lead labeling change processes in document management systems
Ensure global regulatory compliance in all labeling workflows
Analyze large data sets to resolve inconsistencies and improve efficiency
Coordinate with cross-functional teams across regulatory, quality, and supply chain
Maintain and manage master data and workflows using internal systems (e.g., SAP, Windchill)
Identify project risks and drive resolution efforts
Ensure consistent compliance with FDA, EU, GS1, and ISO standards
Support company-wide QMS and EMS initiatives
Required Skills & Qualifications
Bachelor’s degree in Business, Engineering, Supply Chain, or related field
Minimum 5 years of medical device industry experience preferred
At least 2 years leading large-scale, cross-functional programs
Knowledge of FDA, EU, GS1, ISO standards, QMS, UDI
Experience with ERP and PLM systems (preferably SAP and Windchill)
Strong project management, problem-solving, and data analysis skills
Proficiency in Microsoft Excel, PowerPoint, Word, and Access
Excellent verbal and written communication across all levels
Perks & Benefits
Competitive salary: $60,000 – $120,000
Free HIP PPO medical coverage (if eligible)
High-contribution retirement savings plan
Tuition reimbursement and student debt support (Freedom 2 Save)
FreeU educational benefit for bachelor’s degree completion
Global career advancement opportunities
Recognized as a top employer for diversity, innovation, and inclusion
Company Description
Abbott is a global healthcare leader known for innovative medical devices, diagnostics, nutritionals, and branded generics. With over 114,000 employees in 160+ countries, Abbott is committed to improving health outcomes and enhancing quality of life.
Work Mode
On-site – Plymouth, Minnesota
Call to Action
Ready to lead labeling operations in a world-class healthcare company? Apply now and shape the future of structural heart therapies with Abbott.
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