Regulatory Affairs Specialist II – Electrophysiology
Location: Plymouth, Minnesota, United States
Work Mode: On-site
Employment Type: Full-Time
Experience Required: 2–3 Years
Industry: Medical Devices | Regulatory Affairs | Electrophysiology
About Abbott
Abbott is a global healthcare leader dedicated to helping people live healthier, fuller lives at every stage. With a diverse portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines, Abbott serves patients in more than 160 countries through a workforce of over 114,000 professionals. Abbott is consistently recognized as one of the world’s most admired and inclusive employers.
Within Abbott’s Electrophysiology (EP) division, the company is advancing innovative technologies for the treatment of cardiac arrhythmias, including atrial fibrillation, enabling patients to restore heart health and improve quality of life.
Position Overview
Abbott is seeking a Regulatory Affairs Specialist II – Electrophysiology to join its on-site team in Plymouth, Minnesota. This role is responsible for preparing, reviewing, and submitting regulatory documentation to support market entry and lifecycle management of electrophysiology medical devices. The position involves close collaboration with cross-functional teams to ensure compliance with U.S. FDA and global regulatory requirements throughout product development and commercialization.
Key Responsibilities
Prepare and support regulatory submissions for electrophysiology medical devices in alignment with departmental and organizational objectives.
Review and approve engineering change orders, protocols, reports, specifications, and project-related documentation for new product development and sustaining activities.
Act as a regulatory subject matter representative by interpreting and applying applicable U.S. and international regulatory guidelines.
Review internal and external communications to ensure regulatory accuracy, completeness, and compliance with FDA and other global regulatory agency standards.
Maintain current knowledge of domestic and international medical device regulations and ensure accurate documentation within regulatory databases and filing systems.
Communicate new or updated regulatory requirements to relevant stakeholders when required.
Support product release activities by collaborating with Regulatory Operations to ensure timely and compliant product launches.
Interface with the FDA and other regulatory agencies, as assigned, to support regulatory inquiries and submissions.
Support company initiatives related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory frameworks.
Ensure ongoing compliance with company policies, SOPs, and applicable regulatory requirements while fostering effective cross-functional collaboration.
Education & Experience Requirements
Bachelor’s degree or equivalent academic qualification.
2 to 3 years of experience in a regulated industry such as medical devices, pharmaceuticals, diagnostics, or nutritionals.
Experience in regulatory affairs is preferred; however, candidates with relevant experience in quality assurance, R&D, scientific affairs, or operations may be considered.
Advanced education may be considered in lieu of some experience.
Preferred Qualifications
Bachelor’s degree in Life Sciences, Biology, Chemistry, Engineering, Biomedical Sciences, or a related field.
Master’s degree in Regulatory Affairs or a related discipline.
Regulatory experience with capital equipment, including software, firmware, graphical user interfaces, and associated hardware.
Professional certification such as RAC (Regulatory Affairs Certification) is an advantage.
Required Skills & Competencies
Strong understanding of FDA and global medical device regulatory requirements.
Excellent written and verbal communication skills with the ability to engage stakeholders at multiple organizational levels.
Ability to work effectively in a fast-paced, matrixed, and team-oriented environment.
Strong attention to detail and documentation accuracy.
Compensation & Benefits
Competitive base salary range: USD 60,000 – 120,000, depending on location, experience, and qualifications.
Comprehensive health and wellness benefits, retirement savings plans, tuition reimbursement, and career development programs.
Opportunities for professional growth within a globally recognized healthcare organization.
Equal Opportunity Statement
Abbott is an Equal Opportunity Employer committed to fostering diversity, inclusion, and equal employment opportunities for all qualified applicants.
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