Senior Regulatory Quality Specialist – Medical Devices (On-site)
Location: Maple Grove or St. Paul, Minnesota
Company: Abbott Laboratories – Medical Device Division
Work Mode: On-site
Employment Type: Full-Time
Salary Range: $75,300 – $150,700 (location-dependent)
Job Summary
Abbott, a global leader in healthcare innovation, is seeking a Senior Regulatory Quality Specialist to join its medical device division. Based in Maple Grove or St. Paul, Minnesota, this on-site role supports regulatory systems and process development under the Global Regulatory Services (GRS) function. Ideal for professionals with a background in regulatory, quality, or compliance, the role involves leading procedural harmonization efforts, ensuring global regulatory alignment, and managing cross-functional implementation projects for new medical device regulations.
Key Responsibilities
Lead the implementation of regulatory procedural updates across business units
Draft and update regulatory policies, SOPs, and process workflows
Guide internal teams on regulatory risks and strategic decisions
Drive change control activities and documentation compliance
Develop and deliver supplemental training content
Collaborate with IT teams on system enhancements
Maintain quality system documentation in compliance with global standards
Host and document meetings to support regulatory planning and strategy
Analyze quality metrics and trends to support process improvements
Support regulatory operations and system rollouts in coordination with GRS
Required Skills & Qualifications
Bachelor’s degree in a scientific or technical field, or equivalent experience
Minimum 3 years of experience in a regulated industry (e.g., medical products)
2–3 years of direct experience in regulatory affairs or closely related functions
Understanding of submission/registration types and global requirements
Strong communication skills across all organizational levels
Ability to write, edit, and manage complex technical documentation
Excellent organizational and time management skills
Preferred Qualifications
Master’s degree in Regulatory Affairs
5+ years in regulatory or quality roles within the medical device industry
Knowledge of FDA, EU, and global device compliance standards
Experience with Windchill, CAPA processes, and promotional review
Familiarity with GDP, QMS maintenance, and document justification
Certification such as RAC (Regulatory Affairs Certification) preferred
Experience in procedural writing and international product registration
Perks & Benefits
Competitive salary range: $75,300 – $150,700
Free medical coverage under the HIP PPO plan
High employer 401(k) contribution
Tuition reimbursement and student loan assistance
FreeU benefit for bachelor’s degree completion
Global career development opportunities
Inclusive and recognized work culture across 160+ countries
Company Description
Abbott is a global healthcare and medical device innovator focused on advancing patient health through life-changing technologies. With a strong portfolio across diagnostics, cardiovascular therapies, diabetes care, and more, Abbott helps over 10,000 people each day live healthier lives.
Work Mode
On-site – Maple Grove or St. Paul, MN
Call to Action
Take your regulatory career to the next level. Apply now to join Abbott’s industry-leading team and be part of shaping the future of medical device compliance and quality systems.
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