Regulatory Affairs Specialist II – Electrophysiology
Location: Plymouth, Minnesota, United States
Category: Regulatory Affairs
Work Model: On-site
Overview
Abbott is a global leader in healthcare innovation, delivering advanced medical technologies that support better health outcomes across diagnostics, medical devices, nutrition, and branded generic medicines. With a presence in more than 160 countries and over 114,000 professionals, Abbott continues to drive excellence in patient care and regulatory compliance worldwide.
The Electrophysiology (EP) division focuses on transforming the treatment of atrial fibrillation and heart rhythm disorders through advanced medical device technologies. Abbott is seeking an experienced Regulatory Affairs Specialist II to support regulatory strategy, submissions, and compliance for Electrophysiology products.
Position Summary
The Regulatory Affairs Specialist II will support regulatory submissions, documentation management, compliance activities, and product registration processes to ensure Abbott’s electrophysiology devices meet all domestic and international regulatory standards. This on-site role in Plymouth, Minnesota requires strong regulatory expertise, cross-functional collaboration, and the ability to support product lifecycle management.
Key Responsibilities
Prepare, review, and submit regulatory documentation for Electrophysiology medical devices across global regions.
Evaluate and approve engineering change orders, protocols, technical reports, and specifications for both new product development and sustaining projects.
Serve as a regulatory representative, ensuring alignment with FDA, international regulatory requirements, and internal standards.
Maintain up-to-date knowledge of global medical device regulations and ensure accurate documentation in regulatory systems.
Support regulatory operations to enable compliant, timely product releases for global markets.
Assist with FDA interactions and communications as directed.
Ensure adherence to Quality Management Systems (QMS), Environmental Management Systems (EMS), and all company policies.
Communicate effectively across teams, providing regulatory guidance on product requirements and change controls.
Participate in cross-functional initiatives and perform additional duties as assigned.
Required Qualifications
Bachelor’s degree (or equivalent).
2–3 years of experience in a regulated industry such as medical devices, nutritionals, pharmaceuticals, or related fields.
Experience in Regulatory Affairs preferred.
Experience in Quality Assurance, R&D, scientific affairs, or operations may also be considered.
Ability to work in a fast-paced, matrixed environment with cross-functional teams.
Strong written and verbal communication skills.
Preferred Qualifications
Bachelor’s degree in science, engineering, mathematics, or medical-related fields.
Master’s degree in Regulatory Affairs.
Regulatory experience with capital equipment, including software, firmware, user interfaces, and hardware systems.
Why Join Abbott
Opportunities for global career advancement and professional development.
Competitive health benefits and free medical coverage eligibility through the Health Investment Plan (HIP).
High employer contributions to retirement savings programs.
Education support including tuition reimbursement and student debt assistance.
Recognized globally as a top employer committed to diversity, inclusion, and scientific innovation.
Application Information
Advance your Regulatory Affairs career with a world-class organization dedicated to improving patient outcomes. Abbott is an Equal Opportunity Employer committed to diversity and inclusion.
Apply now to join Abbott’s Electrophysiology division in Plymouth, Minnesota.
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