Specialist Regulatory Compliance Emea
vor 2 Wochen
Abbott Medical is looking for a
**Specialist Regulatory Compliance EMEA (m/w/d)**:
based in Eschborn near Frankfurt/ Main or other Abbott Medical sites in Europe
**PURPOSE OF THE JOB**
The 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 & RESPONSIBILITIES**
- Support 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 appropriate
- Create 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 Base
- Support Tender upon request from Regulatory Affairs EMEA
**EDUCATION & COMPETENCIES**
- Knowledge and experience in medical device legislation (MDD, MDR, national legislation)
- Knowledge and experience in post market surveillance
- Experience in cooperation with Competent Authorities
- Technical, natural science, medical background or adequate experience
- Able to cooperate with local teams as well as with the US based manufacturer
- Familiar with Microsoft Office and willingness to work with other databases
- Willingness to meet documentation and follow-up obligations in all areas.
- Fluent in English
**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.
**W**ORKING AT ABBOTT**
At 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 dream of
- An attractive benefits package
- 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.
- A challenging position in a fast-growing crisis independent industry
- To become part of a dynamic, highly educated, highly skilled, and motivated team
- Flat hierarchies, open appreciative mentality, and efficient, constructive lines of communication
- Multi-national environment, where we foster the development of our talents within the enterprise
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.
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