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. **_Specialist Regulatory Affairs_** **Working at Abbott** At Abbott, you can do work that matters, grow and learn, care for yourself and your 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 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** Abbott Molecular has an opening in its **Des Plaines, IL** site for a **Specialist Regulatory Affairs.** Responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day-to-day activities for change control. Provides regulatory direction on team activities. Applies basic regulatory understanding to support of product and teams. Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Handles regulatory activities involved in documentation, labeling, field support. Applies regulatory and technical knowledge to a focused area of work assignments. Understands, implements, and maintains the quality policy. Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures. **What You’ll Work On** + Verifies with supervisory staff and executes regulatory requirements in relation to product development, submissions, product maintenance, project plans. + Implements Division Regulatory Strategy in specific product related activities. + Basic understanding of laws and 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. + Shares knowledge with others in department and on teams. + Provides solutions to a variety of problems where analysis requires moderate degree of evaluation. + Prepares and aligns impact goals with department goals. + Establishes and executes against project goals and implements plans. + Provides input to establishing group plans and implementation of those plans. + Follows GMP guidelines and procedures. + Writes Effectively: Prepares written information in a clear and concise fashion, appropriately designed for varying target audiences. + Responsible for implementing and maintaining the effectiveness of the quality system. + For products division-wide: Advises and communicates to project, group, or venture regarding basic regulatory strategies. + Signs-off at team level within delegated parameters for change control. + Release authority for labeling/sales/promotional materials. + Prepares official correspondence with regulatory agencies under supervisory guidance. + Conducts basic negotiations on routine product related issues with government agencies. + Manages submission-related activities to secure product approval. + Directs daily activities based on team goals and division priorities. + Supports Regulatory Affairs management in resolving compliance issues, ensuring alignment with policies and quality systems. + Obtains supervisory review of submission documents before submission to government agencies. **Required Qualifications** + Bachelor's degree in science, preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, or equivalent experience. + Minimum 2 years relevant professional experience, in a related area such as R&D, Technical Product Development, Quality, Regulatory Affairs, Clinical Research, or Medical Devices. + Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy. + Fluent in word processing, flow diagrams and spreadsheets. **Preferred Qualifications** + 1-2 years of regulatory experience preferably in in-vitro diagnostics. + RAPS Certification Apply Now (https://www.jobs.abbott/us/en) * Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year. **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx) Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews. The base pay for this position is $66,700.00 – $133,300.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com