Regulatory Affairs Specialist II

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. JOB DESCRIPTION: Regulatory Affairs Specialist II 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. Youll 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 bachelors 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 Lake Forest, IL location in the Core Lab Diagnostics Division. Were empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbotts diagnostics instruments, providing lab results for millions of people. The Regulatory Affairs Specialist II is responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day-to-day activities for change control. Provides regulatory directions on team activities. Apply 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, field support. Applies regulatory and technical knowledge to a focused area of work assignments. Understands, implements, and maintains the quality policy. Ensures compliance and is able to demonstrate knowledge of site and division level policies and procedures. What Youll Work On Verifies with supervisory staff and executes regulatory requirements in relation to 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. Share 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. Support projects related to Research Use Only products. Signs-off at 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 prior to submission to government agencies. Required Qualifications Bachelors Degree preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc. Or, and equivalent combinations of education and work experience. Minimum 5-year experience Preferred Qualifications Medical Devices experience preferred. Desire 1-2 years of regulatory experience preferably in in-vitro diagnostics. RAPS Certification preferred. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://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 abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers. The base pay for this position is $68,000.00 $136,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: CRLB Core Lab LOCATION: United States > Lake Forest : CP01 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter