Director, Regulatory Affairs

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 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 high employer contribution - Tuition reimbursement, the [Freedom 2 Save](https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and [FreeU](https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists **The Opportunity** The Director, Regulatory Affairs provides leadership, direction and support for regulatory policy and cross-business regulatory initiatives within the company, actively influencing changing regulations and guidance affecting the company through participation on trade associations and interfaces with regulatory agencies. This person will direct activities associated with capturing domestic and international information both internal and external that impacts the quality, regulatory, and compliance areas of Abbott and keep management abreast of regulatory changes and the impact they could have on the organization. Also, this person will direct and manage cross-business regulatory activities designed to address emerging regulatory issues, incorporate strategic action, and advance the development of Abbott regulatory professionals. This person will be a subject matter expert in the regulatory area organization and serve as a resource that others within the organization can approach for guidance. **What You’ll Work On** Regulatory Intelligence: - Gather, assess, summarize, and disseminate available regulatory information, such as proposed rules and guidance - Develop in conjunction with relevant internal stakeholders, draft, and submit directly to regulatory agencies and trade associations the Abbott position/response to proposed device regulatory policy - Implement processes for monitoring and communicating emerging regulatory issues Cross-Business Initiatives: - Lead cross-business regulatory council consisting of business regulatory heads, legal, government affairs, and AQR - Chair or co-chair council committees designed to execute objectives defined by the regulatory council, such as global conference, emerging issues, talent management - Work across businesses, government affairs, and legal to define, develop, and obtain consensus on Abbott regulatory positions on critical regulatory proposals - Develop and maintain communication strategies for efficient and effective means of cross business information sharing Strategic Planning: - Anticipate regulatory emerging issues and develop solutions to them - Identify need for new regulatory policies/processes - Develop solutions to address emerging regulatory issues with other members of management and stakeholders - Develop corporate positions on regulatory risk-benefit - Create and develop positions and strategies based upon proposed r…