Senior Regulatory Affairs 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 115,000 colleagues serve people in more than 160 countries. Senior Regulatory Affairs Specialist 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Itasca or Chicago, IL (Willis Towers) location in the Abbott Molecular Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. This role is part of the on‑market regulatory team and includes responsibility for performing regulatory impact assessments for changes related to marketed products. The individual may assist in identifying data needed, obtaining data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation. What You’ll Work On Interpret and apply regulatory requirements. Perform regulatory impact assessments to evaluate changes for on‑market products. Compile, prepare, review, and submit regulatory submissions to authorities. Regulatory history, guidelines, policies, standards, practices, requirements, and precedents. Regulatory agency structure, processes, and key personnel. Principles and requirements of applicable product laws. Submission/registration types and requirements. Principles and requirements of promotion, advertising, and labeling. Domestic and international regulatory guidelines, policies, and regulations. Ethical guidelines of the regulatory profession, clinical research, and regulatory process. Required Qualifications Bachelor’s degree (or equivalent); bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. Regulatory experience or relevant industrial experience typically with a quality; product development/ support, scientific affairs function. Preferred Qualifications Two to Three years of experience in regulatory preferred. Three to four years’ experience in a regulated industry (e.g., medical products, nutrition Masters degree in Regulatory Affairs may be used in lieu of direct regulatory experience. Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next year. Abbott is an Equal Opportunity Employer, committed to employee diversity. The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr