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 114,000 colleagues serve people in more than 160 countries.

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.  

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.  

• 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.  
   

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks .   

The Opportunity  

This position works out of our St. Paul, MN location with our Regulatory Affairs team in the Structural Heart division. As an individual contributor, the function of a Regulatory Affairs Coordinator is to provide administrative support for regulatory processes and procedures. The individual may coordinate and support technical and scientific regulatory activities, research regulations and guidance, and organize and m aintain key information sources. The individual may also coordinate departmental activities, including budget tracking, office arrangements, and team events.  

Main Responsibilities  

• Track departmental budget sheets, ensure alignment with invoices and payments, and monitor budget spending status.  

• Handles invoice , cover letter , checks, and other activities related to payment to Regulatory Bodies.  

• Facilitate Regulatory Emerging Issue management by collecting information from various sources, schedule meetings and distribute minutes, track action items, and monitor project status and schedule.  

• Coordinate projects as assigned, to include, but not limited to, project document preparation and ownership, scope definition, communication, planning, executing, monitoring, controlling and closing.  

• On-site support of RA activity planning and coordination, department supplies, and other administrative tasks.  

• Prepare/process legal documents, certificates, and letters for registrations/submissions, tenders/ bids or other purposes.  

• Support simple RA submissions under the guidances of RA specialists, for example, document preparation, submission publishing, and international product renewals.  

• Support other Regulatory Affairs projects by tracking deliverables, coordinate team activities, and perform status updates.  

• Support RA product teams and performs other related duties and responsibilities, as assigned  

• Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.  

Required Qualifications  

• High School Diploma required , Technical Diploma preferred, or an equivalent combination of education and work experience  

• Minimum 3 year of project coordination skills .  

Preferred Qualifications  

• Previous experience in Regulatory Affairs or Quality Assurance  

• Proficiency in Microsoft Suite  

• Strong organizational skills  

• Experience with Regulatory Intelligence (RI) 

The base pay for this position is $23.25 – $46.55 per hour. In specific locations, the pay range may vary from the range posted.

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