Regulatory Affairs Specialist III – Diabetes Care (on-site

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 115,000 colleagues serve people in more than 160 countries.

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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.

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.

We are recruiting for a Regulatory Affairs Specialist III to join our team on-site in Buffalo Grove, IL. 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 Free Style Libre continuous glucose monitors have revolutionized the way roughly 7 million people worldwide manage their diabetes.

This new team member will support manufacturing/operations day-to-day activities for change control and provide regulatory direction on team activities. The individual will apply regulatory understanding to support of product and teams as well as prepare US regulatory submissions and/or registration documents. Additionally, will handle regulatory activities involved in documentation, labeling, field support and apply regulatory and technical knowledge to a focused area of work assignments.

This Specialist understands, implements, and maintains the quality policy and ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

• Verifies with supervisory staff and executes regulatory requirements in relation to product development, submissions, product maintenance and project plans.
• Provide technical leadership and strategic input on complex issues and to business units.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Develop global regulatory strategies for product development and planning throughout the product lifecycle.
• Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
• Implements Division Regulatory Strategy in specific product related activities.
• Basic understanding of medical device regulations.
• Obtains supervisory input for interpretation leading to the solution of issues, and to product development and support.
• Analyzes the input of cumulative product changes to current product submissions.
• Lead functional groups in the development of relevant data to complete a regulatory submission.
• Follows through on…