Regulatory Operations Compliance Manager – Medical Devices (On-site)
Location: Maple Grove or St. Paul, Minnesota
Company: Abbott Laboratories – Global Regulatory Services
Work Mode: On-site
Employment Type: Full-Time
Salary Range: $97,300 – $194,700 (may vary by location)
Job Summary
Abbott is seeking a highly skilled Regulatory Operations Compliance Manager to join its Global Regulatory Services team in Maple Grove or St. Paul, MN. This on-site leadership role is ideal for professionals in regulatory affairs, medical device compliance, or quality assurance, with a passion for implementing emerging regulatory frameworks and harmonizing cross-functional processes. The role blends regulatory strategy, quality leadership, and process optimization across a global healthcare organization.
Key Responsibilities
Lead and implement updates for regulatory procedures and new regulations
Develop and deploy SOPs, regulatory processes, and compliance strategies
Mentor and support regulatory professionals across functions
Drive change management and CAPA processes
Prepare documentation that meets global regulatory standards
Provide strategic input on regulatory risks and quality systems
Host cross-functional meetings and communicate with senior management
Support international product registrations and advertising/promotional reviews
Collaborate with IT teams for system enhancement initiatives
Ensure document control and procedural writing comply with GDP and QMS standards
Required Skills & Qualifications
Bachelor’s degree in a related field or equivalent experience
4+ years in a regulated industry (e.g., medical devices, pharmaceuticals)
2–5 years in regulatory affairs preferred; QA, R&D, or operations acceptable
Strong communication and negotiation skills
Experience with FDA and international regulatory policies
Proven ability to lead cross-functional teams and manage documentation
Familiarity with change control, regulatory SOPs, and system implementation
Preferred Qualifications
Degree in science, engineering, pharmacy, or medical technology
Master’s or PhD in technical discipline
RAC Certification (Regulatory Affairs Professionals Society)
5+ years in regulatory roles
Experience with Windchill, CAPA, and quality systems
International registration support and procedural writing experience
Project management and regulatory change assessment
Deep understanding of global device compliance and GDP practices
Perks & Benefits
Salary range: $97,300 – $194,700
Free HIP PPO medical coverage eligibility
High employer contribution to retirement savings
Tuition reimbursement and FreeU bachelor’s degree access
Student loan assistance through Freedom 2 Save
Global growth and career advancement opportunities
Recognized for diversity, inclusion, and workplace excellence
Work with cutting-edge medical device technologies
Company Description
Abbott Laboratories is a global healthcare pioneer delivering transformative medical devices, diagnostics, and pharmaceutical solutions. With over 114,000 employees in more than 160 countries, Abbott helps people live fuller, healthier lives through innovation and industry-leading products.
Work Mode
On-site – Maple Grove or St. Paul, Minnesota
Call to Action
Ready to lead global regulatory compliance at a world-class healthcare company? Apply today to join Abbott’s Regulatory Services team and shape the future of medical device quality and safety.
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