Specialist Regulatory Compliance EMEA (m/w/d)

Abbott Medical is looking for aSpecialist Regulatory Compliance EMEA (m/w/d)based in Eschborn near Frankfurt/ Main or other Abbott Medical sites in EuropePURPOSE OF THE JOBThe Specialist Regulatory Compliance supports EMEA across the cardiovascular und neuromodulation divisions to comply with regulatory requirements of the MDD, MDR, national legislation in EU and non-EU countries, Switzerland, United Kingdom, Middle East and Africa.ROLES & RESPONSIBILITIESSupport EMEA countries in understanding and knowledge of the medical device legislation (MDD, MDR, national legislation in EU and non-EU countries, Switzerland, United Kingdom, Middle East and Africa)Support countries in the relationship to Competent Authorities, e.g. support Competent Authorities requests for Vigilance Reports or Field Actions.Support countries in Post-Market Surveillance activities, e.g. Product Experience Reporting, Field action coordination and execution.Support Stop Shipments in EMEA countries.Create Training Material and conduct training as appropriateCreate and generate reports, as required for FSCAs and monthly regulatory reports to monitor regulatory compliance.Support Quality Audits in the countries.Support EU and CH Authorized Representative and the Person Responsible for Regulatory Compliance.Support Verification activities as required for Economic Operators according to the MDR and the CH MedDo.Support MDR and CH MedDo projects, e.g. Eudamed, Swissmedic Data BaseSupport Tender upon request from Regulatory Affairs EMEAEDUCATION & COMPETENCIESKnowledge and experience in medical device legislation (MDD, MDR, national legislation)Knowledge and experience in post market surveillanceExperience in cooperation with Competent AuthoritiesTechnical, natural science, medical background or adequate experienceAble to cooperate with local teams as well as with the US based manufacturerFamiliar with Microsoft Office and willingness to work with other databasesWillingness to meet documentation and follow-up obligations in all areas.Fluent in EnglishABOUT ABBOTTAbbott 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 ABBOTTAt Abbott, you can do work that matters and help people to live a healthier and full life, grow your career, and learn, be your true self. You will have access to: Career development with an international company where you can grow the career you dreamofAn attractive benefits packageA company recognized as a great place to work in dozens of countries around the worldandnamed 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. A challenging position in a fast-growing crisis independent industryTo become part of a dynamic, highly educated, highly skilled, and motivated teamFlat hierarchies, open appreciative mentality, and efficient, constructive lines of communicationMulti-national environment, where we foster the development of our talents within the enterprise