Sr Regulatory Quality Specialist2 – Medical Devices (On-site)
Location: Maple Grove or St. Paul, MN
Company: Abbott Laboratories – Global Regulatory Services
Work Mode: On-site
Job Type: Full-Time
Salary Range: $75,300 – $150,700 (location-dependent)
Job Summary
Abbott is hiring a Senior Regulatory Quality Specialist for its Medical Devices division at either Maple Grove or St. Paul, Minnesota. This on-site role within the Global Regulatory Services (GRS) function is ideal for professionals experienced in regulatory affairs, compliance, and quality systems in the medical device or healthcare industry. The role focuses on managing regulatory systems, implementing new regulations, and ensuring compliance through process optimization.
Key Responsibilities
Lead procedural updates and implement emerging regulations
Develop regulatory policies, processes, and SOPs
Facilitate procedural rollouts across cross-functional teams
Evaluate and mitigate regulatory risks in policies and operations
Create and deliver supplemental training materials
Manage regulatory system projects and change orders
Lead cross-functional meetings and document outcomes
Analyze quality metrics, identify trends, and recommend improvements
Collaborate with IT teams to enhance regulatory workflows
Ensure adherence to document quality systems and GDP
Required Skills & Qualifications
Bachelor’s degree or equivalent experience
Minimum 3 years in a regulated industry (medical, nutritionals, etc.)
2–3 years of regulatory experience preferred
Knowledge of regulatory submissions/registration types
Strong technical writing and verbal communication skills
Effective multitasking, prioritization, and organization
Attention to detail and follow-up skills
Preferred Qualifications
Master’s in Regulatory Affairs
5+ years in a regulated industry
Regulatory knowledge (FDA, EU, ICH, ISO, etc.)
Experience in CAPA, procedural writing, and Windchill
Regulatory Change Assessment and Ad/Promo Review experience
International Product Registration and Quality System compliance
Familiarity with medical device regulatory frameworks
RAC certification is a plus
Understanding of global regulatory precedents and guidelines
Perks & Benefits
Competitive salary: $75,300 – $150,700
Free HIP PPO medical coverage eligibility
High employer contribution to retirement savings
Tuition reimbursement and FreeU degree program
Student debt support via Freedom 2 Save
Global mobility and internal advancement programs
Inclusive and award-winning workplace culture
Company Description
Abbott is a global healthcare innovator, providing breakthrough technologies in diagnostics, medical devices, nutrition, and branded generics. With a presence in over 160 countries and a workforce of 114,000+, Abbott empowers people to live healthier, fuller lives through world-class medical solutions and regulatory excellence.
Work Mode
On-site – Maple Grove or St. Paul, Minnesota
Call to Action
Ready to lead regulatory excellence at a global medical device leader? Apply now to join Abbott’s Global Regulatory Services team and help shape the future of healthcare compliance.
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