Regulatory Affairs Specialist II

1 week ago

Minneapolis, Minnesota, United States Abbott Laboratories Full time
Job Opportunity

Abbott Laboratories is seeking a highly skilled Regulatory Affairs Specialist II to join our team in Plymouth, MN. As a key member of our Electrophysiology business, you will play a critical role in advancing the treatment of heart disease through breakthrough medical technologies.

Key Responsibilities

  • Prepare and submit regulatory applications, including annual reports, to ensure compliance with regulatory agency specifications.
  • Develop and maintain knowledge of domestic and international medical device regulations to ensure submission requirements are current and up-to-date.
  • Collaborate with cross-functional teams to support product release and ensure compliance with regulatory standards.
  • Interface with regulatory agencies, such as the FDA, to ensure compliance with regulatory requirements.
  • Support the development and implementation of regulatory strategies to ensure compliance with company policies and procedures.

Requirements

  • Bachelor's degree in a relevant field, such as science, math, or engineering.
  • 2-3 years of experience in a regulated industry, preferably in regulatory affairs or a related field.
  • Strong communication and analytical skills, with the ability to work effectively in a team environment.
  • Proficient in MS Office suite, including Word, Excel, and Outlook.

Preferred Qualifications

  • Certification in regulatory affairs, such as RAC from the Regulatory Affairs Professionals Society.
  • Experience with regulatory submission data bases and file systems.

About Abbott Laboratories

Abbott Laboratories 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.

Why Join Us?

At Abbott Laboratories, 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.

Apply Now

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 Laboratories for diverse opportunities with a company that can help you build your future and live your best life. Abbott Laboratories 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.

The base pay for this position is $57,300.00 – $114,700.00. In specific locations, the pay range may vary from the range posted.

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