**Regulatory Affairs Manager** **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **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 Will Have Access To • Career development with an international company where you can grow the career you dream of. • 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** This position works at Istanbul location in the Core Diagnostics Division that 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. Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. **What You'll Do** **Primary Objective of Position** + Responsible for regulatory compliance and registration for Core Diagnostics in Turkey, Georgia, Lebanon, Azerbaijan and Iran. + Monitors, assesses, and reports changes to regulatory requirements or new requirements to Area Regulatory Affairs and supports the Regulatory Intelligence process. **Major Accountabilities** + Responsible for the implementation of regulatory compliance as required by international and local regulations and Abbott policies and procedures + Responsible for product registration and maintenance of regulatory approval of all Core Diagnostics products intended for distribution in Turkey, Georgia, Lebanon, Azerbaijan and Iran. + Engages with Distributors and liaise with country Regulatory Authorities. + Monitors local regulations, e.g. language requirements and medical event reporting and support Regulatory Intelligence process. + Develops and executes strategies to comply with regulations to achieve early market entry and cost-effective business operation while maintaining regulatory compliance. + Participates and represents Abbott Core Diagnostics in trade association meetings and at conferences. + Manages Vigilance and Field Action reporting for Adverse Events. + Represents RA in audits. + Leads, develops, and mentors Regulatory staff. **Required Qualifications:** + Bachelor’s degree in engineering, life sciences or equivalent. + 3-5 years of managerial experience in the Medical Device/IVD industry, preferably in Regulatory Affairs or Quality Assurance. + Knowledge of PC-based application. + Technical skills related to IVD or Medical Devices. + Fluent in English (written and spoken). + Experience to work in international environment/ projects. Cultural sensibility. + Preferably several years’ experience in the Medical Device/IVD industry. **Apply Now** 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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com