Regulatory Coordinator

Job Description

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 109,000 colleagues serve people in more than 160 countries.

About Abbott

Leading an active lifestyle is important to the many people we serve. In Abbott’s Electrophysiology and Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives.

Our location in St. Paul, MN currently has an opportunity for a Regulatory Affairs Coordinator.

WHAT YOU’LL DO

• Technical support for regulatory agency submissions

• Process Certificates for Foreign Governments and of Free Sale

• Assistance in CAPA administration, data collection and metrics, payment of Regulatory filing and registration fees

• Complete Registrations and Listings and ensure business unit sites and listings remain active and accurate on FDA database and other geographies requiring registrations

• Document management for the department

• Assist in preparation of submissions (e.g. letters, submissions packages, Acrobat linking, mailing)

• Provide regulatory support for all product-specific activities related to gaining and maintaining market approval

• Interface and support Team Members of the Regulatory Affairs staff.

• Complete administrative duties including but not limited to: presentations, scheduling of on- and 0ff-site meetings including webcasts, department meetings and meetings with and visits to Regulators.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelor’s degree preferred, high school degree required
• 1-3 years of experience in a similar position
• Medical Device industry experience with emphasis on highly regulated products is preferred
• Ability to multi-task efficiently
• Persistent and engaged; a good communicator
• Must work well within a collaborative team environment
• Excellent computer application skills, including: Excel, Word and Adobe

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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.