Title: Regulatory Affairs Specialist II – Electrophysiology (On-site)
Location: Plymouth, Minnesota, USA
Employment Type: Full-time
Experience Required: 2–3 years in regulated industries (medical devices, diagnostics, or life sciences)
Company Overview:
Abbott is a global healthcare leader dedicated to improving lives at every stage. With a diverse portfolio across diagnostics, medical devices, nutritionals, and branded generics, Abbott serves over 160 countries, providing innovative technologies that transform patient care. Our Electrophysiology (EP) division is advancing the treatment of heart disease through breakthrough technologies in atrial fibrillation, helping patients restore health and quality of life.
Role Overview:
Abbott is seeking a Regulatory Affairs Specialist II to join the EP team on-site in Plymouth, MN. This role focuses on preparing, evaluating, and submitting regulatory documentation for EP devices, ensuring compliance with domestic and international regulatory requirements. The position supports product market entry, sustaining activities, and new product development projects.
Key Responsibilities:
Prepare and submit regulatory documentation for Electrophysiology devices to meet departmental and organizational objectives.
Review and approve engineering change orders, protocols, reports, specifications, and related documentation.
Act as a regulatory representative, ensuring compliance with FDA and other global regulatory requirements.
Maintain current knowledge of domestic and international medical device regulations and update internal systems.
Support product release processes by collaborating with Regulatory Operations to ensure timely and compliant product availability.
Interface with regulatory agencies, including FDA, as directed.
Ensure compliance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and company policies.
Support additional company initiatives as assigned, contributing to regulatory excellence and inspection readiness.
Required Qualifications:
Bachelor’s degree in Life Sciences, Engineering, or related field (or equivalent experience).
2–3 years of experience in regulated industries, preferably in regulatory affairs, quality assurance, R&D, or scientific operations.
Strong verbal and written communication skills, with ability to effectively interact at multiple organizational levels.
Ability to work effectively in a fast-paced, matrixed team environment.
Preferred Qualifications:
Bachelor’s degree in Science (Biology, Chemistry, Microbiology), Engineering, or Medical field; Master’s in Regulatory Affairs is a plus.
Regulatory experience with capital equipment including software, firmware, GUIs, and hardware.
RAC certification or equivalent regulatory credentials preferred.
Why Join Abbott:
Global career development and growth opportunities with a leading healthcare company.
Comprehensive benefits including medical coverage, retirement plans, tuition assistance, and employee wellness programs.
Recognized globally as a top employer for diversity, inclusion, and career development.
Competitive compensation: base pay $60,000 – $120,000 (location-dependent).
Equal Opportunity Employer:
Abbott is committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other protected status.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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