Regulatory Affairs Manager, fixed-term 2 years (m/f/x)

Trust something new, grow beyond itself and redefine the boundaries of the feasible. That is exactly what our employees can and should live daily. To set the pace with our innovations and make it great. Because there are a lot of fascinating people behind every successful company. ZEISS employees work in an open and modern environment with numerous development and further training opportunities. Our culture is characterized by expert knowledge and team spirit. All this is supported by the special ownership structure and the long-term goal of the Carl-Zeiss Foundation: to advance science and society together.

Today dare. Inspire tomorrow.

Diversity is part of ZEISS. We look forward to your application regardless of gender, nationality, ethnic and social origin, religion, world view, disability, age as well as sexual orientation and identity.

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Seeing beyond - future of medical technology

For more than 100 years, the medical technology of ZEISS has been driving progress in ophthalmology and microsurgery. In ophthalmology, our solutions help to maintain and improve the vision of people at any time of life. In microsurgery, our solutions enable targeted interventions on the diseased tissue, so that small and sensitive organs continue to function optimally ZEISS's medical technology supports medical professionals to improve the lives of patients worldwide. The fact that we have a direct influence on the well-being of our people is our daily drive.

In this role, you work on national and international registrations of newly developed medical devices, as well as change reports and change registrations of existing products

Initiate and follow queries regarding the country-specific registration requirements at our country representatives and distributors

You manage and update the regulatory status in databases and storage systems

You are responsible for creating and filing the regulatory dossier according to specific requirements from countries

You manage and maintain country-specific documentation and pass on necessary adjustments and correction requirements from country representations and distributors to internal interfaces

You regularly agree with country representations, distributors and internal interfaces regarding the submission dates, deadlines and comparable “logistic” topics

You continually deepen your knowledge of international registration requirements

You have successfully completed at least three years of university education (e.g. Bachelor) in a technical, economic, business or comparable course of study

You ideally have first professional experience in Regulatory Affairs in medical technology or a comparable professional experience, e.g. in Quality Management or Clinical Affairs

You have first project management experience and very good knowledge in MS Office and common software tools

You possess pronounced analytical skills

You have fun in solving complex issues and are characterized by your independent and solution-oriented approach

You have very good oral and written communication skills to exchange views with different stakeholders and interfaces, including external partners and regulatory authorities

You have knowledge of English in word and writing; another foreign language is advantageous

You have ideally gained first experience in dealing with standards, laws and regulatory requirements

You ideally have knowledge of regulatory requirements in individual markets such as AMERICAS, EMEA, ASEAN