Job Title: Senior Regulatory Affairs Specialist – Electrophysiology (On-site)
Location: Plymouth, Minnesota, United States
Category: Regulatory Affairs
About Abbott
Abbott is a global healthcare leader dedicated to helping people live more fully at all stages of life. The company’s diverse portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines, employing 114,000 colleagues across 160+ countries.
Working at Abbott
At Abbott, you’ll do work that matters—helping people live healthier, fuller lives—while developing your own career and well-being.
Employee Benefits Include:
Career development in a global, growth-driven company.
Free medical coverage (Health Investment Plan – HIP PPO) for eligible employees.
Excellent retirement savings plan with high employer contribution.
Tuition reimbursement, Freedom 2 Save student debt program, and FreeU degree benefit.
Recognized globally as one of the Most Admired Companies by Fortune and as a Best Place to Work for diversity, women, scientists, and working mothers.
About the Electrophysiology (EP) Business
Abbott’s Electrophysiology (EP) division is advancing the treatment of heart disease through innovative medical technologies for atrial fibrillation—helping people restore their health and lead active lives.
The Opportunity
Abbott is seeking an experienced Senior Regulatory Affairs Specialist to join the on-site team in Plymouth, MN.
In this role, you will lead regulatory submissions and approvals, provide regulatory guidance to cross-functional teams, and help shape global strategies for device compliance and market access.
Key Responsibilities
Prepare and submit robust regulatory applications to achieve departmental and business objectives.
Serve as Regulatory Affairs representative on product development teams—communicating regulatory requirements and assessing regulatory impact.
Provide regulatory guidance on global strategies in collaboration with international affiliates.
Compile, review, and submit medical device applications to regulatory agencies.
Interface directly with the FDA and other international authorities.
Act as liaison between Abbott and regulatory bodies, ensuring accurate and comprehensive communication.
Monitor and analyze domestic and international medical device regulations; update internal systems and distribute key regulatory updates.
Review device labeling to ensure compliance with FDA and global standards.
Support the product release process through GTS license creation or approval reviews.
Review product and manufacturing changes for compliance with regulatory requirements.
Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other compliance initiatives.
Ensure adherence to FDA, ISO, and international regulatory requirements.
Maintain collaborative and professional communication with employees, customers, vendors, and regulatory agencies.
Provide mentorship and leadership to other Regulatory Affairs team members.
Required Qualifications
Bachelor’s Degree in a technical discipline (e.g., Biology, Chemistry, Microbiology, Immunology, Medical Technology, etc.).
Minimum 2 years of regulatory or relevant industrial experience (e.g., Quality, Product Development, or Scientific Affairs).
Preferred Qualifications
4+ years of regulatory submission experience in medical device, pharmaceutical, or healthcare industries.
Advanced degree preferred.
Experience with Class II or Class III medical devices.
Hands-on experience with PMA supplements, 510(k) applications, and U.S./EU medical device regulations.
Familiarity with risk management, design verification, and process validation.
Proficiency with MS Office Suite (Word, Excel, Outlook).
Experience in matrixed and geographically diverse organizations.
Excellent verbal and written communication skills, with ability to communicate at multiple organizational levels.
Compensation
Base Pay Range: $75,300.00 – $150,700.00
(Actual range may vary based on location and experience.)
Why Join Abbott
Competitive compensation, incentives, and retirement benefits.
Comprehensive healthcare coverage (medical, dental, vision, wellness).
Paid time off and professional development support.
Opportunities for long-term growth in a stable, global organization.
Learn more at 👉 www.abbottbenefits.com
Equal Opportunity Employer
Abbott is an Equal Opportunity Employer committed to diversity, inclusion, and equal employment opportunities for all qualified individuals.
Connect with Abbott
🌐 www.abbott.com
📘 Facebook: Abbott
🐦 Twitter: @AbbottNews | @AbbottGlobal
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