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Principal Regulatory Affairs Specialist – Electrophysiology (On-Site)

5+ years
$85,300 – $170,700
10 July 4, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.