Regulatory Affairs Manager (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.

Apply now! In less than 10 minutes. 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.

They define and implement regulatory, international approval strategies for complex, demanding development projects for innovative microsurgical applications in the field of intra-operative visualization and digital imaging in neurosurgery as well as microsurgical products

They work and run projects for authorisations or changed requirements triggered by legislative changes (e.g. EU MDR)

You create independent submission dossiers for the global approval of medical devices

You report and monitor the approval status sustainably

They act as contact persons for internal areas (R&D, project management, product management, marketing communications, clinical affairs, international RA contact persons in the respective markets) and externally for partners and authorities

They drive the optimization of global regulatory affairs processes across locations

You check and approve product-specific marketing materials

They continuously work in project teams for product new and new developments from product definition to market launch

a completed higher education in a technical, economic, business or comparable course of study

several years of experience in Regulatory Affairs in medical technology or comparable professional experience in industry

Analytical skills and creativity as well as communication strength and organizational skills within an international environment

Project management experience as well as knowledge of economic relationships and their application

very good knowledge of English and German in word and writing; further language skills are advantageous

very good knowledge of MS Office and common software tools

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