Senior Regulatory Specialist

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.

     

JOB DESCRIPTION:

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 

Our mission is to help people with heart failure survive and thrive. At Abbott’s Heart Failure (HF) business, we pioneer and increase access to lifesaving, connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis to monitoring and treatment. 

The Opportunity 

This Senior Regulatory Affairs Specialist will work out of our Pleasanton, CA location in the Heart Failure Division. As an individual contributor in the function of a Sr. Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department. With limited supervision you will execute tasks and partner across business functions. 

As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities.  

What You’ll Work On  
• As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. 
• Interacts with FDA and other regulatory agency to expedite approval of pending registration. 
• Serves as regulatory liaison throughout product lifecycle. 
• Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, 
• Ensures timely approval of