Regulatory Affairs Specialist II | Abbott, Plymouth, MN (On-site)
Job Summary
Abbott, a global leader in healthcare and medical technology, is seeking a Regulatory Affairs Specialist II for its Electrophysiology division in Plymouth, Minnesota. This on-site role involves preparing and managing regulatory submissions for electrophysiology mapping and imaging devices, ensuring compliance with FDA and international standards, and supporting market entry processes across global regions.
Key Responsibilities
Prepare regulatory submissions for electrophysiology devices to achieve organizational objectives.
Review and approve engineering change orders, protocols, reports, and project documentation.
Serve as regulatory representative ensuring compliance with global standards including FDA guidelines.
Evaluate internal and external communications for adherence to regulatory standards.
Maintain up-to-date knowledge of global medical device regulations and ensure accurate database entries.
Collaborate with Regulatory Operations to ensure compliant product release processes.
Potential direct interface with FDA and other regulatory authorities.
Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory initiatives.
Ensure compliance with U.S. FDA, international regulations, and company policies.
Perform additional related duties as assigned.
Required Skills & Qualifications
Bachelor’s degree or equivalent in science, engineering, or a related field.
2-3 years’ experience in a regulated industry (medical devices, nutritionals, or related areas).
Background in regulatory affairs preferred; experience in quality assurance or R&D acceptable.
Strong verbal and written communication skills across multiple organizational levels.
Ability to work effectively in a fast-paced, matrixed environment.
Preferred Skills & Qualifications
Master’s degree in Regulatory Affairs.
Experience with regulatory processes for capital equipment including software, firmware, GUIs, and hardware.
Scientific degree in biology, chemistry, microbiology, math, or medical fields.
Perks & Benefits
Competitive Salary Range: $60,000 – $120,000 annually.
Free medical coverage via Health Investment Plan (HIP) PPO.
Excellent 401(k) retirement plan with high employer contribution.
Tuition reimbursement, Freedom 2 Save student debt program, FreeU education benefit.
Opportunities for global career advancement and professional development.
Company Description
Abbott is a world-class healthcare and diagnostics leader providing innovative medical technologies that improve patient care worldwide. With 114,000 employees across 160 countries, Abbott focuses on diagnostics, medical devices, nutrition, and branded pharmaceuticals.
Work Mode
On-site — Plymouth, Minnesota, United States.
Call to Action
Ready to advance your regulatory career with a global healthcare leader? Apply now to join Abbott’s pioneering team in electrophysiology devices and shape the future of medical technology.
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