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Labeling Project Manager

2-5 years
$60,000 – $120,000 annually
10 July 29, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.