Job Title: Regulatory Affairs Specialist II – Electrophysiology (On-site)
Location: Plymouth, Minnesota, USA
Employment Type: Full-time
Experience Required: 2–3 years in regulated industries (medical devices, diagnostics, or life sciences)
Company Overview:
Abbott is a global healthcare leader, committed to improving lives at all stages. With a portfolio spanning diagnostics, medical devices, nutritionals, and branded generics, Abbott operates in over 160 countries, delivering technologies that transform patient care. Abbott’s Electrophysiology (EP) division focuses on innovative solutions for treating heart conditions, including atrial fibrillation, enabling patients to restore health and quality of life.
Role Overview:
Abbott is seeking a Regulatory Affairs Specialist II to join the EP team on-site in Plymouth, MN. This role involves specialized work in preparing, reviewing, and submitting regulatory documentation to ensure compliance with FDA and international regulatory requirements. The position supports both new product introductions and sustaining activities, contributing to safe and compliant market entry of medical devices.
Key Responsibilities:
Prepare, review, and submit regulatory documentation for Electrophysiology devices to meet organizational objectives.
Review and approve engineering change orders, protocols, reports, specifications, and related documentation.
Serve as a regulatory representative, analyzing and interpreting applicable regulatory guidelines.
Ensure communications and documentation comply with FDA and international regulatory standards.
Maintain up-to-date knowledge of domestic and international medical device regulations and ensure documentation in regulatory submission databases.
Collaborate with Regulatory Operations to support compliant and timely product releases.
Interface with FDA and other regulatory agencies when required.
Support company initiatives related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Comply with FDA regulations, international standards, company policies, and internal procedures.
Perform additional duties as assigned to support Abbott’s regulatory and quality objectives.
Required Qualifications:
Bachelor’s degree or equivalent in Science, Engineering, or a related field.
2–3 years of experience in a regulated industry (medical devices, diagnostics, or life sciences). Regulatory affairs experience preferred; quality assurance, R&D, scientific affairs, or operations experience considered.
Ability to work in a fast-paced, matrixed team environment.
Strong verbal and written communication skills, capable of interacting across multiple organizational levels.
Preferred Qualifications:
Bachelor’s degree in Biology, Chemistry, Microbiology, Engineering, or Medical field.
Master’s degree in Regulatory Affairs.
Experience with regulatory submissions for capital equipment, including software, firmware, GUIs, and associated hardware.
Why Join Abbott:
Global career growth opportunities and international exposure.
Comprehensive benefits including medical coverage, retirement plans, tuition assistance, and wellness programs.
Recognized worldwide for diversity, inclusion, and as one of the most admired companies globally.
Competitive compensation: base pay $60,000 – $120,000 (location-dependent).
Equal Opportunity Employer:
Abbott is committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other protected status.
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