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

     

JOB DESCRIPTION:

About Abbott

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.

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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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.

The Opportunity

This Regulatory Affairs Specialist III position will work on-site out of our Austin, TX location in the Abbott Diabetes Care Division. This role supports change control for manufacturing/operations activities and provides regulatory direction on cross functional projects. This new team member will apply basic regulatory understanding to support products and teams and will prepare U.S. regulatory submissions and/or registration documents for the US FDA as well as international affiliates and government agencies worldwide. This individual contributor will handle regulatory activities involved in ensuring quality of documentation to support a variety of product and process changes, with a particular focus on those relating to the manufacturing environment. This new hire will understand, implement, and maintain the quality policy, along with ensuring compliance to and demonstrating knowledge of site and division level policies and procedures.

What You’ll Work On

• Executes regulatory deliverables in relation to product development, submissions, product maintenance, and project plans.
• Implements Division Regulatory Strategy as they apply to supporting product and process change projects.
• Leverage basic understanding of laws and regulations to ensure compliance.
• Interprets regulations to propose solutions to issues and to support product development.
• Analyzes the input of cumulative product changes to existing cleared product submissions and drafts letter to file documentation to support regulatory assessment as appropriate.
• Shares knowledge with others in department and on cross functional teams.
• Responsible for implementing and maintaining the effectiveness of the quality management system.
• Official correspondence with outside regulatory agencies as guided by supervisory staff.
• Conducts basic negotiations on routine product related issues with government agencies.
• Follows through on submission related deliverables to secure product approval/clearance.
• Directs own daily activities in alignment with team goals and division regulatory priorities.
• Interface with Abbott’s third party manufacturing partners and suppliers to ensure efficient collaboration and compliant resolution of issues, as well as to assist in international registration of manufacturing sites.

Required Qualifications

• Bachelor’s Degree or an equivalent combination of education and experience
• 5 years’ work experience

Preferred Qualifications

• Bachelor’s degree in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
• 5+ years’ experience in Medical Devices
• 1-2 years of regulatory experience.
• Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Communicate effectively verball