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Sr Regulatory Quality Specialist2 – Medical Devices (On-Site)

3-5 years
$75,300 – $150,700
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

 

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.