Regulatory Affairs Manager (m/w/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 make a sign with our innovations and to enable great. Because there are a lot of fascinating people behind every successful company. In an open and modern environment with numerous development and further training opportunities, ZEISS employees work in a culture characterised 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 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. Your duties You prepare registration projects for new developments and changes

They independently analyze regulatory requirements of international regulations and the application to complex products and develop alternative solutions and risk mitigation measures

They ensure early consideration of regulatory requirements in development and change projects

You check and evaluate the implementation options with your interfaces, e.g. R&D, Product Management, Clinical Affairs, Marketing Communications, ZEISS Sales and Service Center (SSC) & Distributors for complex products

They develop the approval strategy for complex products in markets with high registration requirements in coordination with stakeholders such as product managers and business managers

They implement the approved authorisation strategies in countries with complex authorisation requirements for complex products

You check and evaluate registration requirements for possible and meaningful implementation, development of alternative options

You negotiate and submit accordingly to the competent authority / registration office directly or via SSC / Distributor

They work strategically with the SSC and internal interfaces for obtaining/maintaining approval

You plan, manage and coordinate complex registration projects until you obtain the approval and report the project status

Higher education in a technical, scientific, economic or comparable course of study

Multiannual experience in Regulatory Affairs in medical technology or comparable professional experience in industry

Understanding clinical applications

Project management experience

Embossed analytical skills combined with creativity and intuition

Knowledge of regulatory and economic relationships and their strategic application

Very good knowledge of MS Office and common software tools (e.g. SAP, document management tools)

Intercultural competence and fun in active exchange with global and diverse teams and management of stakeholders

Ability to drive and moderate decisions combined with high organizational talent and prioritization

English and German knowledge in word and writing

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