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. **Working at Abbott** At Abbott, you can do work that matters, grow, learn, care for yourself and your family, be your true self, and live a whole life. You will also have access to: + Career development with an international company where you can grow the career you dream of. + Free medical coverage will be included 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’sdegree. + Recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies by Fortune. + Recognized as one of the best big companies to work for and the best place to work for diverse employees, working parents, female executives, and scientists. **The Opportunity** We have an opportunity for the role of **Regulatory Specialist** within our Core division based out of Lake Forest, IL. Regulatory Specialists will be 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 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, and field support. Applies regulatory and technical knowledge to a focused area of work assignments. Understands, implements, and maintains the quality policy. Ensures compliance with and demonstrates knowledge of site and division-level policies and procedures. **What** **You’ll** **Work On** + Verifies with supervisory staff and executes regulatory requirements about product development, submissions, product maintenance, and 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 the department and on teams. + Provides solutions to a variety of problems where analysis requires a 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 clearly and concisely, 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 the project, group, or venture regarding basic regulatory strategies. + Signs off at the team level within delegated parameters for change control. + Release authority for labeling/sales/promotional materials. + Official correspondence with outside regulatory agencies is guided by supervisory staff. + Conducts basic negotiations on routine product-related issues with government agencies. + Follows through on submission-related activities to secure product approval. + Directs own daily activities by utilizing team goals and division regulatory priorities. + Provides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system. + Obtains supervisory regulatory review on submission documents before submission to government agencies. **Required Qualifications:** + Bachelor'sDegree (± 16 years), preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc + 1-2 years of regulatory experience in the relevant field. **Preferred Qualifications** + 5 years of experience in the related field is preferred. + RAPS Certification preferred. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com 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, Facebook at www.facebook.com/Abbott, and 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