Regulatory Affairs Specialist II – Electrophysiology (On-Site)
Location: Plymouth, Minnesota, United States
Employment Type: Full-Time, On-Site
Category: Regulatory Affairs – Medical Devices
Experience Required: 2–3 years in a regulated industry
About Abbott
Abbott is a global healthcare leader dedicated to improving lives at all stages. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generics, serving over 160 countries with innovative solutions. Abbott’s Electrophysiology (EP) business develops cutting-edge technologies for the treatment of heart disease, including advanced solutions for atrial fibrillation, helping patients restore health and lead fuller lives.
Abbott is recognized globally as a top employer for career growth, diversity, and innovation.
Role Overview
Abbott is seeking a skilled Regulatory Affairs Specialist II to join our Electrophysiology team on-site in Plymouth, MN. This role is responsible for regulatory submissions, documentation, and compliance activities to support product market entry. The ideal candidate ensures adherence to domestic and international regulatory requirements and contributes to Abbott’s mission of delivering safe and effective medical devices.
Key Responsibilities
Prepare and manage regulatory submissions for Electrophysiology devices to meet departmental and organizational objectives.
Review and approve engineering change orders, protocols, reports, specifications, and project documentation for both new product development and sustaining activities.
Serve as a regulatory representative by reviewing and analyzing applicable regulatory guidelines.
Evaluate communications to ensure compliance with FDA and global regulatory standards, and disseminate relevant updates to internal teams.
Maintain up-to-date knowledge of domestic and international medical device regulations, entering requirements into regulatory databases and file systems.
Collaborate with Regulatory Operations to ensure compliant and timely product release.
Interface with FDA and other regulatory agencies as directed.
Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory initiatives.
Ensure compliance with FDA regulations, international standards, internal policies, SOPs, and procedures.
Maintain positive, cooperative communication with employees, contractors, vendors, and stakeholders.
Required Qualifications
Bachelor’s degree (or equivalent combination of education and work experience) in Science, Engineering, or a related field.
2–3 years of experience in a regulated industry (medical devices, nutritionals, or pharmaceuticals). Regulatory experience is preferred, but candidates with QA, R&D, scientific affairs, operations, or related experience will also be considered.
Strong verbal and written communication skills, with the ability to interact effectively across organizational levels.
Ability to work collaboratively within a fast-paced, matrixed environment.
Preferred Qualifications
Advanced degree (Master’s) in Regulatory Affairs or related field.
Regulatory experience with capital equipment, including software, firmware, graphical user interfaces, and associated hardware.
Regulatory Affairs Certification (RAC) is a plus.
Experience in global regulatory submissions and navigating international medical device regulations.
Compensation & Benefits
Base salary: USD 60,000 – 120,000 (may vary by location and experience).
Comprehensive health coverage through the Health Investment Plan (HIP) PPO.
Retirement savings plan with high employer contribution.
Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefit.
Career development opportunities within a global healthcare leader recognized for innovation and inclusion.
Why Abbott
Abbott fosters an inclusive and dynamic work environment where employees can grow professionally while making a tangible impact on global healthcare. Join Abbott’s Electrophysiology team to advance heart health and contribute to breakthrough medical technologies.
Abbott is an Equal Opportunity Employer, committed to diversity, equity, and inclusion in all hiring and employment practices.
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