Instagram
youtube
Facebook

Regulatory Operations Compliance Manager – Medical Devices (On-Site)

5+ years
$97,300 – $194,700 annually
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

 

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.