Position Title:
Regulatory Affairs Specialist II – Electrophysiology (On-site)
Location:
Plymouth, Minnesota, USA
Department:
Regulatory Affairs
Company Overview:
Abbott is a global healthcare leader dedicated to improving lives through diagnostics, medical devices, nutritionals, and branded generic medicines.
114,000 employees in over 160 countries.
Recognized globally as one of Fortune’s Most Admired Companies and one of the Best Big Companies to Work For.
Known for fostering diversity, inclusion, and career growth opportunities.
Abbott’s Electrophysiology (EP) division develops breakthrough medical technologies that advance the treatment of heart disease, particularly atrial fibrillation, helping patients restore heart health and live fuller lives.
The Opportunity:
Abbott seeks an experienced and motivated Regulatory Affairs Specialist II to join the Electrophysiology Division at the Plymouth, MN site.
You will be responsible for preparing, reviewing, and submitting documentation for regulatory registration and ensuring compliance with FDA and international regulations to support product market entry.
Key Responsibilities:
Regulatory Submissions & Documentation
Prepare and manage regulatory submissions for electrophysiology devices to meet company and departmental goals.
Review and approve engineering change orders, protocols, reports, and technical documentation for new product development and sustaining projects.
Act as a regulatory representative, ensuring compliance with FDA and international standards.
Review and evaluate internal and external communications for adherence to applicable regulatory requirements.
Compliance & Information Management
Maintain up-to-date knowledge of domestic and international medical device regulations.
Update and manage regulatory submission databases and file systems.
Ensure that new or modified regulations are communicated to relevant internal stakeholders.
Support the product release process by coordinating with the Regulatory Operations team for timely and compliant product launches.
Interface directly with the FDA or other regulatory agencies when required.
Ensure full compliance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Cross-Functional Collaboration
Collaborate effectively with engineering, quality, and operations teams to support regulatory strategy and execution.
Maintain positive and cooperative relationships across departments, customers, and vendors.
Support company initiatives as defined by management.
General Responsibilities
Comply with FDA, international, and company regulations and procedures.
Perform other duties as assigned, contributing to Abbott’s regulatory excellence and compliance culture.
Required Qualifications:
Bachelor’s degree (or equivalent combination of education and experience).
2–3 years of experience in a regulated industry (medical devices, nutritionals, or related).
Preferably in Regulatory Affairs, but QA, R&D, or Operations experience may be considered.
Strong communication skills (verbal and written) across multiple organizational levels.
Ability to work effectively in a team-based, fast-paced, matrixed environment.
Preferred Qualifications:
Bachelor’s degree in Science, Engineering, Math, or Medical fields (e.g., Biology, Chemistry, Microbiology).
Master’s degree in Regulatory Affairs (preferred).
Experience with capital equipment, including software, firmware, GUIs, and related hardware.
Compensation & Benefits:
Base Pay Range: $60,000 – $120,000 (may vary by location).
Health Benefits: Free medical coverage eligibility under Abbott’s Health Investment Plan (HIP).
Retirement Plan: High employer contribution.
Education Benefits:
Tuition reimbursement
Freedom 2 Save student debt program
FreeU bachelor’s degree program
Global career growth opportunities and leadership development support.
Application & Contact:
🔗 Apply Now: www.abbottbenefits.com
🌐 Learn More: www.abbott.com
📱 Connect:
Facebook: facebook.com/Abbott
Twitter: @AbbottNews
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