Regulatory Affairs Intelligence Specialist

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.

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.

This position serves as the Medical Devices Regulatory Affairs (RA) Global Regulatory Compliance process lead; collaborates cross-functionally as needed and keeps MD informed of key global regulatory changes and status of assessment / implementation for compliance via the QMS Process.    WHAT YOU’LL DO   Global Regulatory Operations is seeking a  Regulatory Affairs Intelligence Specialist  to join our team in St. Paul, MN.  This position is focused on new and changing regulations that enable global market access for new and innovative medical devices and supports compliance continuity for marketed devices. Assisting in the process to evaluate proposed regulatory changes in major markets including the US, EU, Canada, Australia, Brazil, Japan, the Regulatory Affairs Intelligence Specialist:  Monitors and fact-checks new or changing global regulations  Tracks and documents regulations within the regulatory intelligence systems  Supports the communication of emerging regulations, documents for comment, and regulations in implementation  Performs regulatory investigations to assess medical device regulatory changes within a specific country or region  Supports the maintenance of, or continuous improvement of quality system procedures, and documents  May train others on systems and processes  Facilitates the collection and reporting of data in support of key performance indicators  Gathers additional data to support interpretation, and aid businesses in determining impact  Support all company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements  Complies with regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, etc.  Performs other related duties and responsibilities, on occasion, as assigned      Required Qualifications  Bachelors Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience  Minimum 2-3 years experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.  Experience with Regulatory history,