Principal Regulatory Affairs Specialist US New Product Introduction Diabetes Care (on-site)

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.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the student debt program and 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.

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That's why we're focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.

The Opportunity

The Principal RA Specialist US New Product Introduction will work on-site out of our Alameda, CA location in the Diabetes Care Division. We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology. Our FreeStyle Libre continuous glucose monitors has revolutionized the way roughly 6 million people worldwide manage their diabetes. This is an exciting opportunity with responsibilities for US submissions for new product introductions, which include breakthrough advancement in diabetes management and digital health technology solutions to address the spectrum of customer needs.

Projects will focus on premarket submissions for our portfolio of continuous glucose monitoring systems. Working knowledge of insulin and drug solutions for diabetes management or past experience in submitting NDA / BLA submissions is preferred. The individual has department level influence with experience in US submissions and on-market changes, and is generally recognized as an expert resource both within Abbott and externally. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics / information.

What You'll Work On

Required Qualifications

Preferred Qualifications

The base pay for this position is $98,000.00 $196,000.00. In specific locations, the pay range may vary from the range posted.