Regulatory Affairs Specialist II – Electrophysiology
Location: Plymouth, Minnesota, United States
Category: Regulatory Affairs
About Abbott
Abbott is a global healthcare leader dedicated to improving lives across all stages of health. With a broad portfolio in diagnostics, medical devices, nutrition, and branded generic medicines, Abbott operates in more than 160 countries and employs over 114,000 professionals worldwide.
About the Role
The Regulatory Affairs Specialist II supports key regulatory activities for Abbott’s Electrophysiology (EP) business. This on-site role in Plymouth, Minnesota, focuses on preparing, evaluating, and submitting regulatory documentation to support product approvals and compliance with global regulatory standards. The position is essential to enabling timely market entry and maintaining regulatory compliance for EP technologies that advance the treatment of atrial fibrillation.
Key Responsibilities
Regulatory Submissions and Documentation
Prepare and submit regulatory documentation for Electrophysiology devices to support global market access.
Review and approve engineering change orders, protocols, reports, and technical documentation for both new product development and sustaining activities.
Serve as a regulatory representative, interpreting and applying relevant FDA and international regulatory guidelines.
Review technical communications to ensure clarity, accuracy, and compliance with global regulatory standards.
Regulatory Compliance and Data Management
Maintain up-to-date knowledge of domestic and international medical device regulations.
Ensure regulatory requirements are updated in submission databases and shared with cross-functional teams when needed.
Support product release processes in coordination with the Regulatory Operations team to ensure compliant and timely market availability.
Assist with FDA and international regulatory agency communications as directed.
Quality and Cross-Functional Collaboration
Support initiatives aligned with the Quality Management System (QMS), Environmental Management System (EMS), and other regulatory frameworks.
Ensure compliance with U.S. FDA regulations, international standards, internal policies, and procedural requirements.
Maintain effective collaboration with internal teams, vendors, contractors, and customers.
Perform additional duties as assigned by leadership.
Required Qualifications
Bachelor’s degree (or equivalent).
2–3 years of experience in a regulated industry such as medical devices or nutritionals.
Regulatory experience preferred; experience in Quality Assurance, R&D, Scientific Affairs, or Operations may be considered.
Higher education may offset experience requirements.
Ability to work effectively in a fast-paced, matrixed team environment.
Strong verbal and written communication skills with the ability to engage across organizational levels.
Preferred Qualifications
Bachelor’s degree in a scientific or technical discipline (biology, chemistry, microbiology, mathematics, engineering, etc.).
Master’s degree in Regulatory Affairs.
Experience with regulatory submissions involving capital equipment, software, firmware, graphical user interfaces, and associated hardware.
Professional certification such as RAC (Regulatory Affairs Certification).
Why Join Abbott
Career development opportunities within a global organization.
Eligibility for free medical coverage through the Health Investment Plan (HIP) PPO.
Competitive retirement savings program with strong employer contributions.
Tuition reimbursement, student loan assistance (Freedom 2 Save), and FreeU bachelor’s degree support.
Recognized globally as a leading employer committed to diversity, inclusion, and scientific excellence.
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