Principal Regulatory Affairs Specialist – Electrophysiology (On-site, USA)
Job Summary
Join Abbott's Electrophysiology Division as a Principal Regulatory Affairs Specialist based on-site in Plymouth or St. Paul, Minnesota. This senior-level role is perfect for professionals with expertise in global regulatory submissions for medical devices (Class II/III), FDA filings (IDE, PMA, 510(k)), and international compliance. With a competitive salary range of $85,300 to $170,700, this opportunity offers an excellent career path in a globally recognized healthcare company.
Key Responsibilities
Develop global strategies for regulatory approval of new and modified Class II/III medical devices.
Prepare and submit regulatory documentation (IDE, 510(k), PMA, EU Dossiers, etc.).
Act as SME during audits and regulatory inspections.
Represent Regulatory Affairs in cross-functional product teams.
Maintain up-to-date knowledge of worldwide regulatory changes and ensure compliance.
Liaise with internal teams, regulatory agencies, and in-country affiliates.
Review product and manufacturing changes for regulatory impact.
Mentor junior team members in regulatory processes and documentation standards.
Required Skills & Qualifications
Bachelor’s degree in Chemistry, Life Sciences, or related scientific discipline.
5+ years of regulatory affairs experience with Class II/III medical devices.
Strong knowledge of US and international regulations (FDA 21 CFR 820, ISO 13485, MDD 93/42/EEC, IVDD 98/79/EC).
Hands-on experience with submissions such as IDE, 510(k), PMA supplements.
Familiarity with quality systems, clinical investigations, and regulatory software.
Strong written and verbal communication skills.
Regulatory Affairs Certification (RAC) is preferred.
Perks & Benefits
Competitive base pay ($85,300–$170,700) plus performance incentives
Free medical coverage through Health Investment Plan (HIP)
Excellent 401(k) with high employer contribution
Tuition reimbursement and FreeU bachelor’s degree program
Paid parental leave and family care support
Career advancement in a global healthcare leader
Recognized as a top employer for diversity, working mothers, and innovation
Company Description
Abbott is a global leader in healthcare, committed to helping people live healthier and fuller lives. Operating in over 160 countries, Abbott offers cutting-edge innovations in diagnostics, medical devices, nutrition, and branded generics, including transformative solutions in cardiovascular and electrophysiology medicine.
Work Mode
On-site – Plymouth, MN or St. Paul, MN (USA)
Call-to-Action
Ready to drive global regulatory success at one of the world’s most admired healthcare companies?
Apply now to join Abbott’s expert regulatory team and advance life-changing electrophysiology technology!
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