Senior Regulatory Affairs Specialist – Electrophysiology (On-Site)
Location: Plymouth, Minnesota, United States
Category: Regulatory Affairs
Employment Type: Full-Time, On-Site
Experience Required: Minimum 2 years in regulatory or related medical device/pharmaceutical roles
About Abbott
Abbott is a global healthcare leader delivering innovative solutions that help people live healthier, fuller lives at all stages. Our portfolio spans medical devices, diagnostics, nutritionals, and branded generics, serving millions worldwide. With 114,000 colleagues across 160+ countries, Abbott combines scientific innovation and regulatory excellence to transform healthcare outcomes.
Abbott’s Electrophysiology (EP) business focuses on advancing the treatment of heart disease through cutting-edge technologies for atrial fibrillation, improving patient quality of life and restoring health.
Role Overview
Abbott is seeking a Senior Regulatory Affairs Specialist to join the Electrophysiology team on-site in Plymouth, MN. This role provides regulatory leadership, guiding cross-functional teams through global submission strategies, regulatory approvals, and compliance for medical devices. The position also mentors junior team members and ensures that regulatory processes align with both domestic and international requirements.
Key Responsibilities
Lead preparation, review, and submission of regulatory applications for Class II and Class III medical devices, including PMA supplements, 510(k) applications, and international submissions.
Serve as regulatory representative on product development teams, providing guidance on worldwide strategies and regulatory impacts.
Maintain up-to-date knowledge of domestic and international medical device regulations and ensure compliance with submission requirements.
Interface directly with FDA and other regulatory authorities, ensuring clear and effective communication.
Review device labeling, product and manufacturing changes, and support product release processes.
Support business initiatives in alignment with Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory frameworks.
Provide mentoring and regulatory leadership to team members.
Ensure all regulatory activities comply with company policies, operating procedures, and legal requirements while maintaining collaborative communication across all organizational levels.
Required Qualifications
Bachelor’s degree in a technical discipline (e.g., biology, chemistry, microbiology, immunology, medical technology, pharmacy, or related field).
Minimum 2 years of regulatory experience or relevant industry experience in quality, product development/support, scientific affairs, or a related function.
Strong written and verbal communication skills with the ability to interact at multiple organizational levels.
Preferred Qualifications
4+ years of regulatory submission experience in medical devices, pharmaceuticals, or healthcare products.
Advanced degree (Master’s or PhD) in a relevant technical or scientific discipline.
Experience with Class II/III medical devices, PMA supplements, 510(k) applications, and international regulatory submissions.
Familiarity with risk management, design verification, and process validation.
Proficiency in MS Office (Word, Excel, Outlook).
Experience working in a matrixed, geographically diverse organization.
Ability to mentor junior team members and provide leadership in regulatory strategy.
Why Join Abbott
Career growth and professional development in a leading global healthcare company.
Comprehensive health and wellness benefits including medical, dental, vision, and wellness programs.
Competitive retirement savings plans and tuition assistance.
Opportunity to work on innovative cardiovascular and electrophysiology technologies impacting patient lives globally.
Learn more: www.abbottbenefits.com
Abbott is an Equal Opportunity Employer, committed to diversity and inclusion.
Base Salary: $75,300 – $150,700 (location-dependent)
Apply Now to advance your career as a Senior Regulatory Affairs Specialist with Abbott.
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