Regulatory Affairs Specialist III - Diabetes Care (on-site)

Regulatory Affairs Specialist III – Buffalo Grove, IL Job Summary We are recruiting for a Regulatory Affairs Specialist III to join our team on-site in Buffalo Grove, IL. This role supports manufacturing and operations day‑to‑day activities for change control, provides regulatory direction on team activities, and prepares U.S. regulatory submissions and registration documents. The specialist will manage documentation, labeling, field support, and ensure compliance with site and division level policies and procedures. Responsibilities Verify and execute regulatory requirements in relation to product development, submissions, product maintenance, and project plans. Provide technical leadership and strategic input on complex regulatory issues to business units. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with regulatory and related teams. Develop global regulatory strategies for product development and planning throughout the product lifecycle. Analyse and compare regulatory outcomes with initial product concepts and recommend future strategies and actions. Implement division regulatory strategy in specific product-related activities. Maintain a basic understanding of medical device regulations. Seek supervisory input for interpretation leading to issue resolution in product development and support. Analyze cumulative product changes to current product submissions. Lead functional groups in developing relevant data for regulatory submissions. Follow through on submission‑related activities to secure product approval. Share knowledge with others in the department and cross‑functional teams. Establish and execute against project goals and implement plans. Provide input to establish group plans and support implementation. Follow GMP guidelines and procedures. Prepare written information clearly and concisely for varying audiences. Implement and maintain the effectiveness of the quality system. Administer and meet regulatory requirements to achieve compliance with no enforcement actions. Advise and communicate basic regulatory strategies to project groups or ventures. Sign off at the team level within delegated parameters for change control. Direct own daily activities using team goals and division regulatory priorities. Support Regulatory Affairs management in resolving compliance issues, ensuring alignment with site and division policies and quality systems. Obtain supervisory regulatory review on submission documents prior to government submission. Required Qualifications Bachelor’s degree or equivalent combination of education and experience. Five years’ work experience in a related field. Preferred Qualifications Bachelor’s degree in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, engineering, or related field. Five or more years’ experience in the medical device industry. One to two years of regulatory experience. Demonstrated ability to communicate, prepare, and negotiate both internally and externally with regulatory agencies. Ability to follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issues. Strong analytical and problem‑solving skills. Experience with 510(k), PMA, or other international regulatory submissions. RAPS certification. Benefits Career development opportunities with an international company. Eligibility for free medical coverage in the Health Investment Plan (HIP) PPO medical plan. High employer contribution to an excellent retirement savings plan. Tuition reimbursement and student debt program options. Other educational benefits to support bachelor’s degree attainment. Recognition as a great place to work, diversity champion, and support for working mothers. Compensation $68,000.00 – $136,000.00 (may vary by location) Job Family Regulatory Operations Division ADC Diabetes Care Location United States > Buffalo Grove: 1250 Barclay Blvd Work Shift Standard Travel Yes, 5 % of the time Medical Surveillance No Significant Work Activities Awkward/forceful/repetitive movements (arms above shoulder, bent wrists); Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8‑hour day) Equal Employment Opportunity Statement Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law. English: . Spanish: . #J-18808-Ljbffr Dormont Manufacturing Company