Principal Regulatory Affairs Specialist – Electrophysiology | Plymouth or St. Paul, MN (On-site)
Job Summary:
Abbott’s Electrophysiology Division is hiring a Principal Regulatory Affairs Specialist to lead the development and execution of global regulatory strategies for Class II/III medical devices. This on-site position in Plymouth or St. Paul, Minnesota, is ideal for a regulatory affairs professional with in-depth knowledge of U.S. FDA submissions (510(k), PMA, IDE) and international regulations. You’ll partner cross-functionally and play a key role in ensuring compliant and timely product registrations that improve cardiovascular health outcomes worldwide.
Key Responsibilities:
Develop and implement global regulatory strategies for new and modified electrophysiology products
Prepare robust FDA submissions (IDE, 510(k), PMA Supplements), EU Dossiers, and country-specific regulatory filings
Lead cross-functional collaboration during product development and regulatory approvals
Serve as Subject Matter Expert (SME) for internal audits and external inspections
Maintain global regulatory intelligence and ensure database and document compliance
Act as liaison with regulatory authorities, Notified Bodies, and in-country affiliates
Support license creation, product listings, and change control documentation
Review product and manufacturing changes for regulatory compliance
Mentor junior regulatory specialists and support knowledge sharing across teams
Participate in strategic projects and departmental process improvements
Required Skills & Qualifications:
Bachelor’s degree in Chemistry, Biology, Life Sciences, or related scientific field
Minimum 5 years of regulatory experience with Class II/III medical devices
Proven experience in FDA submissions (IDE, 510(k), PMA) and international device registrations
Working knowledge of 21 CFR 820, ISO 13485, and EU MDR/MDD
Strong understanding of QMS, risk management, and clinical investigations
Excellent written and verbal communication skills across technical and executive audiences
Ability to work independently and collaboratively in a matrixed, fast-paced environment
Regulatory Affairs Certification (RAC) preferred
Perks & Benefits:
Salary Range: $85,300 – $170,700 (location-dependent)
Free employee medical coverage via HIP PPO plan
Generous employer contributions to 401(k) retirement plan
Tuition reimbursement and education benefits (Freedom 2 Save, FreeU)
Paid time off, wellness programs, and career development resources
Diverse, inclusive, award-winning workplace recognized globally
Company Description:
Abbott is a global healthcare leader delivering medical device innovations across diagnostics, nutrition, and cardiovascular care. The Electrophysiology Division pioneers cutting-edge technologies that restore heart rhythm health and improve patient outcomes. Abbott operates in over 160 countries, empowering lives through science.
Work Mode:
On-site – Plymouth or St. Paul, Minnesota
Call to Action:
Are you ready to lead global regulatory affairs initiatives that make a difference in cardiovascular health? Apply now to join Abbott as a Principal Regulatory Affairs Specialist and advance your impact in the medical device industry.
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