Regulatory Affairs Specialist II – Electrophysiology (On-Site)
Location: Plymouth, Minnesota, United States
Employment Type: Full-Time, On-Site
Category: Regulatory Affairs – Medical Devices
Experience Required: 2–3 years in a regulated industry
About Abbott
Abbott is a global healthcare leader dedicated to helping people live healthier and fuller lives. Our portfolio spans medical devices, diagnostics, nutritionals, and branded generics, serving over 160 countries. Abbott’s Electrophysiology (EP) division focuses on innovative treatments for heart disease, including advanced solutions for atrial fibrillation, improving patient outcomes worldwide.
Abbott is recognized as a top employer globally for career growth, diversity, and inclusion.
Role Overview
We are seeking a Regulatory Affairs Specialist II to join our Electrophysiology team on-site in Plymouth, MN. This role involves preparing regulatory submissions, reviewing documentation, ensuring compliance with FDA and international regulations, and supporting all regulatory activities required for product market entry.
The ideal candidate will have strong regulatory knowledge, effective communication skills, and the ability to operate in a fast-paced, cross-functional environment.
Key Responsibilities
Prepare and manage regulatory submissions for Electrophysiology devices to meet departmental and organizational objectives.
Review and approve engineering change orders, protocols, reports, specifications, and related documentation for new product development and sustaining activities.
Serve as a regulatory representative by reviewing and analyzing applicable domestic and international regulatory guidelines.
Evaluate communications to ensure adherence to FDA and global regulatory standards and disseminate critical regulatory information to internal teams.
Maintain regulatory compliance by tracking domestic and international medical device regulations in submission databases and file systems.
Collaborate with Regulatory Operations to ensure compliant and timely product release to support Abbott customers.
Interface with FDA and other regulatory agencies as directed.
Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other company regulatory initiatives.
Maintain cooperative communication with employees, contractors, vendors, and stakeholders.
Perform other related regulatory duties as assigned.
Required Qualifications
Bachelor’s degree (or equivalent combination of education and work experience) in Science, Engineering, or related field.
2–3 years of experience in a regulated industry (medical devices, nutritionals, pharmaceuticals). Regulatory experience is preferred but candidates with QA, R&D, scientific affairs, operations, or related experience will be considered.
Strong verbal and written communication skills, with the ability to effectively interact across multiple organizational levels.
Ability to work collaboratively in a fast-paced, matrixed environment.
Preferred Qualifications
Master’s degree in Regulatory Affairs or related field.
Regulatory experience with capital equipment, including software, firmware, graphical user interfaces, and associated hardware.
Regulatory Affairs Certification (RAC) is a plus.
Experience with international regulatory submissions and navigating global medical device regulations.
Compensation & Benefits
Base Salary: $60,000 – $120,000 (may vary by location and experience).
Comprehensive health coverage under Abbott’s Health Investment Plan (HIP) PPO.
Retirement savings plan with high employer contribution.
Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefit.
Career development opportunities in a global healthcare leader recognized for innovation, diversity, and inclusion.
Why Join Abbott
Abbott fosters a collaborative, inclusive, and innovative work environment where employees grow professionally while making a meaningful impact on global healthcare. Join the Electrophysiology team to advance heart health and contribute to breakthrough medical technologies.
Abbott is an Equal Opportunity Employer, committed to diversity, equity, and inclusion across all hiring and employment practices.
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