Regulatory Affairs Specialist II – Electrophysiology (On-site)
Location: United States – Minnesota – Plymouth
Category: Regulatory Affairs
Company Overview
Abbott is a global healthcare leader helping people live more fully at all stages of life. Its diverse portfolio includes diagnostics, medical devices, nutritionals, and branded generic medicines. Abbott employs 114,000+ people across 160 countries, driving innovation that improves global health outcomes.
Working at Abbott
At Abbott, you can:
Build your career through international opportunities and professional growth.
Qualify for free medical coverage in the Health Investment Plan (HIP) PPO.
Access an excellent retirement savings plan with high employer contribution.
Benefit from tuition reimbursement, the Freedom 2 Save program, and FreeU (a low-cost bachelor’s degree path).
Be part of one of Fortune’s Most Admired Companies, recognized globally for:
Diversity and inclusion
Support for working mothers and female executives
Outstanding workplace culture for scientists and innovators
Division Overview: Electrophysiology (EP)
Abbott’s Electrophysiology business advances the treatment of heart rhythm disorders through cutting-edge medical technologies.
Its mission: to restore heart health and enable people to live healthier, more active lives — particularly those with atrial fibrillation.
The Opportunity
Position: Regulatory Affairs Specialist II
Location: Plymouth, MN (On-site)
This role involves preparing and managing regulatory submissions for Abbott’s Electrophysiology devices, ensuring compliance with global regulatory standards. The specialist supports both new product development and marketed product maintenance, helping enable safe, compliant access to lifesaving cardiac technologies.
Key Responsibilities
Regulatory Documentation & Submissions
Prepare and submit regulatory documentation for EP devices in line with organizational goals.
Review and approve engineering change orders (ECOs), protocols, reports, and specifications.
Support regulatory activities required for new product market entry.
Regulatory Compliance & Communication
Act as a regulatory representative for interpreting and applying regulatory guidelines.
Review communications to ensure adherence to FDA and international regulatory standards.
Maintain up-to-date knowledge of global medical device regulations and integrate updates into internal systems and databases.
Disseminate new or revised regulatory information to relevant departments as required.
Collaboration & Product Support
Collaborate with Regulatory Operations to ensure compliant and timely product release.
Interface with FDA and other regulatory agencies as directed.
Support company initiatives related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and other compliance frameworks.
Quality & Compliance
Ensure adherence to:
U.S. FDA regulations
International medical device regulations
Company SOPs and processes
Maintain cooperative communication with colleagues, customers, and vendors to uphold compliance and efficiency.
General Responsibilities
Perform additional regulatory duties as assigned by management.
Required Qualifications
Education: Bachelor’s degree (or equivalent).
Experience: 2–3 years in a regulated industry (medical products, nutritionals, etc.).
Preferred focus: Regulatory Affairs.
Other acceptable areas: Quality Assurance, R&D, Scientific Affairs, or Operations.
Higher education may substitute for experience.
Skills:
Strong written and verbal communication across all organizational levels.
Ability to function effectively in fast-paced, matrixed team environments.
Preferred Qualifications
Bachelor’s Degree in Science (Biology, Chemistry, Microbiology, Engineering, or related fields).
Master’s Degree in Regulatory Affairs.
Regulatory experience with capital equipment, software, firmware, GUIs, and hardware.
Certification (e.g., RAC) from the Regulatory Affairs Professionals Society (RAPS).
Compensation
Base Pay Range: $60,000 – $120,000
(May vary by specific location.)
Application Details
Learn more about Abbott’s health and wellness benefits:
🌐 www.abbottbenefits.com
Connect with Abbott:
Website: www.abbott.com
Facebook: facebook.com/Abbott
Twitter: @AbbottNews
Equal Opportunity Employer: Abbott is committed to employee diversity, inclusion, and equal opportunity.
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