Regulatory Affairs Manager - International Compliance Operations – Structural Heart (on-site)

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 **Structural Heart Business Mission: why we exist** Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. This individual contributor role is based on-site at our St. Paul/New Brighton, MN facility within Abbott’s Structural Heart Division. The candidate will leverage expertise in scientific, regulatory, and business considerations to ensure products developed, manufactured, or distributed comply with all applicable regulations. This team member will support multiple product lines and therapies, serving as a recognized subject-matter expert and mentor within the department. **WHAT YOU’LL DO** - Prepare robust regulatory applications (FDA and international regulatory agencies) to achieve departmental and organizational objectives - Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes - Support pre and post approval submission activities - Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams - Assess the acceptability of development, quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submissions to authorities - Negotiate and interact with regulatory authorities during review process to ensure submission approval - Ensure compliance with US and global product post marketing approval requirements - Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies - Execute and manage technical and scientific regulatory activities. Must function independently as a decisionmaker on regulatory issues and must assure that deadlines are met - Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. - Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units - Provide leadership and guidance towards achieving department objectives and act as a mentor to less-experienced staff - May lead a cross-functional or cross-divisional project team - Responsible for compliance with applicable Corporate and Divisional Policies and procedure…