Sr. Regulatory Affairs Manager

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: 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. 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, Sr. Regulatory Affairs Manager, works out of our Lake Forest, IL location on site in the Infectious Diseases Division. This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs. We’re 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 Abbott’s diagnostics instruments, providing lab results for millions of people. What You’ll Work On We are seeking a highly knowledgeable individual contributor will be expected to combine expertise in scientific, regulatory, and business issues to ensure our products meet required legislation. This role involves significant departmental influence and recognition as an expert resource both within Abbott and externally. The individual will ensure data is identified, obtained, and effectively presented for product registration worldwide Strategic Planning: Identify new regulatory policies, processes, and SOPs in addition to evaluating regulatory risks of current corporate policies. CLIA Waiver, Lateral Flow, International experience are important in this role, the ideal candidate will have experience in all of these areas. Provide guidance for product development and planning throughout the product lifecycle. Analyze regulatory outcomes with initial product concepts and recommend future strategies and actions. Develop and update global regulatory strategies based on regulatory changes. Conduct regulatory due diligence for potential and new acquisitions and advise management. Utilize technical regulatory skills to propose strategies on complex issues. Monitor emerging issues and identify solutions. Monitor trade association positions for impact on company products. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with regulatory and related teams. Recruit, develop, and mentor regulatory professionals. Premarket: Monitor the impact of changing regulations on submission strategies and update internal stakeholders. Communicate application progress to internal stakeholders. Monitor and submit applicable reports and responses to regulatory authorities. Negotiate with regulatory authorities during the development and review process to ensure submission approval. Provide input and technical guidance on regulatory requirements to development teams. Manage preapproval compliance activities. Required Qualifications Bachelor's degree, preferably in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. 6 years' experience in a regulated industry, 6 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience. Preferred Qualifications A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) CLIA WAIVER, and Lateral Flow experience of at least a few years is ideal. Regulatory Knowledge: Background in IVD instruments and software. Experience with meeting global (i.e., US FDA, IVDR, PMDA) cybersecurity, EMC, and software requirements. Regulatory history, guidelines, policies, standards, practices, requirements and precedents. 7 years of experience. Regulatory agency structure, processes and key personnel. Principles and requirements of applicable product laws. Knowledge of Principles and Requirements of promotion, advertising and labeling international treaties and regional, national, local and territorial trade requirements. Agreements and considerations: Domestic and international regulatory guidelines, policies and regulations Ethical guidelines of the regulatory profession, clinical research and regulatory process. 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 $113,300.00 – $226,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: ID Infectious Disease LOCATION: United States > Lake Forest : J55 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: No 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 it’s 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 life’s 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