Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

Regulatory Affairs Specialist I

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of .

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with high employer contribution

• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our St Paul, MN., location, supporting our Electrophysiology division. This position performs 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.

What You’ll Work On

• Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives.

• Creates, reviews and approves engineering changes.

• Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.

• Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.

• Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested.

• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.

• May interface directly with FDA and other regulatory agencies if so directed.

• Reviews protocols and reports to support regulatory submissions.

• Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

• Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelors' degree

Preferred Qualifications

• Med Device experience

• Regulatory experience

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.