Regulatory Affairs Specialist II – Electrophysiology (on-site)

Abbott; Minneapolis (MN); On-site; USD 50,000 - 100,000; Full time

Job summary

A leading company in healthcare is seeking a passionate Regulatory Affairs Specialist II for their Plymouth, MN location. This role involves ensuring compliance for Electrophysiology devices through preparation of regulatory submissions and interfacing with regulatory agencies. Candidates should possess a relevant degree and have 2-3 years of experience in a regulated environment, demonstrating strong teamwork and communication skills.

Qualifications

• 2-3 years’ experience in a regulated industry.
• Regulatory experience with capital equipment preferred.

Responsibilities

• Perform regulatory submissions for Electrophysiology Mapping and Imaging devices.
• Ensure compliance with FDA and international regulations.
• Act as a regulatory representative and support product release processes.

Skills

Strong communication

Teamwork

Education

Bachelor’s degree or equivalent

Master’s degree in Regulatory Affairs

Job description

Regulatory Affairs Specialist II – Electrophysiology (on-site)

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Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. Responsibilities include preparation of regulatory submissions for Electrophysiology Mapping and Imaging devices, review and approval of engineering change orders, acting as a regulatory representative for review and analysis of applicable regulatory guidelines, reviewing and evaluating communications for regulatory compliance, maintaining up-to-date knowledge of domestic and international medical device regulations, supporting product release processes, interfacing with FDA and other regulatory agencies if directed, supporting company initiatives related to Quality Management Systems and Environmental Management Systems, and complying with FDA and international regulations and company policies. Required qualifications include a Bachelor’s degree (or equivalent), 2-3 years’ experience in a regulated industry, ability to work in a team environment, and strong communication skills. Preferred qualifications include a Bachelor’s degree in science, math, engineering, or medical fields, a Master’s degree in Regulatory Affairs, and regulatory experience with capital equipment including software, firmware, graphical user interfaces, and associated hardware.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Hospitals and Health Care

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