Job Title:
Regulatory Operations Compliance Project Manager – Medical Devices (On-site)
Location:
Maple Grove, MN
St. Paul, MN
(On-site position)
Category:
Regulatory Affairs
About Abbott
Abbott is a global healthcare leader helping people live more fully at all stages of life.
Its portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines, with over 114,000 colleagues serving in more than 160 countries.
Working at Abbott
At Abbott, you can do meaningful work, grow personally and professionally, and live a fulfilling life.
Benefits Include:
🌍 Global career development opportunities
💊 Free medical coverage (HIP PPO) for eligible employees
💰 Excellent retirement savings plan with high employer contribution
🎓 Tuition reimbursement, Freedom 2 Save student debt program, and FreeU degree pathway
🏆 Recognized by Fortune as one of the World’s Most Admired Companies and a Great Place to Work
👩🔬 Named among the Best Big Companies for diversity, women, scientists, and working mothers
About Abbott’s Medical Devices Division
Abbott’s medical device technologies provide faster, more effective, and minimally invasive solutions for major health challenges.
They support treatment for heart disease, diabetes, chronic pain, and movement disorders, improving the lives of hundreds of thousands of patients daily.
The Opportunity
Abbott is seeking a Regulatory Operations Compliance Project Manager to join its team on-site at either Maple Grove or St. Paul, Minnesota.
This role, under Global Regulatory Services, focuses on managing projects related to regulatory process harmonization across Abbott’s Medical Device Division.
As an individual contributor, the Project Manager will combine expertise in Regulatory, Quality, and Compliance to ensure implementation of global regulatory changes and procedural improvements, collaborating with:
International regulatory affiliates
Cross-Business Unit (BU) regulatory teams
Cross-functional departments
This position requires a strong regulatory mindset and the ability to lead complex, strategic discussions and initiatives across the organization.
Key Responsibilities
Regulatory Process & Compliance Management
Lead regulatory process and procedure updates across business units
Implement emerging regulatory requirements into internal documentation
Develop, author, and revise regulatory policies, SOPs, and guidance documents
Facilitate procedure implementation and compliance training
Drive change order activities and maintain documentation within the Quality System
Strategic & Technical Leadership
Provide strategic input and technical guidance on regulatory decisions
Evaluate and mitigate regulatory risks associated with policies or procedures
Lead and mentor regulatory professionals to strengthen compliance knowledge
Develop and deliver training materials and management presentations
Cross-Functional & IT Collaboration
Collaborate with Abbott IT on regulatory process workflows and system enhancements
Lead cross-functional team meetings; document and track action items
Author communications and reports for senior management
Required Qualifications
Bachelor’s Degree in a related scientific, technical, or regulatory field (or equivalent work experience)
Minimum 4 years experience in a regulated industry (e.g., medical devices, pharmaceuticals, nutritionals)
2–5 years of experience in Regulatory Affairs, or related areas such as Quality Assurance, R&D, or Scientific Affairs
Strong written and verbal communication skills
Knowledge of domestic and international regulatory guidelines, policies, and procedures
Proven ability to lead cross-functional groups and manage regulatory submissions
Preferred Qualifications
Familiarity with Regulatory Affairs functions and medical device submission processes
Proven success managing multiple projects and priorities
Bachelor’s degree in Biology, Chemistry, Microbiology, Immunology, Medical Technology, Pharmacy, Pharmacology, Engineering, or related field
Master’s or Ph.D. in a technical discipline (preferred)
RAC certification (Regulatory Affairs Professionals Society) – preferred
5+ years experience in a regulated industry
Experience with:
CAPA (Corrective and Preventive Action)
Windchill document management system
Procedural writing and regulatory change assessment
International product registration support
Advertising and promotional material review
Quality system maintenance and GDP (Good Documentation Practice)
Strong project management and stakeholder communication skills
Compensation
💰 Base Pay Range:
$97,300.00 – $194,700.00 USD
(May vary depending on location.)
Additional Information
Learn more about Abbott’s benefits and opportunities:
🔗 www.abbottbenefits.com
🔗 www.abbott.com
📱 Facebook: facebook.com/Abbott
🐦 Twitter: @AbbottNews
Abbott is an Equal Opportunity Employer, committed to diversity and inclusion.
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