Regulatory Affairs Manager Digital (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 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 analyze regulatory requirements of international regulations and their application to digital products

As Regulatory Affairs (RA) Expert Development and Change Projects

They examine and evaluate the feasibility, registration requirements and risks, taking into account feasibility and alternatives, as well as time factors

They develop admission strategies and drive the implementation of digital medical devices in markets with divergent registration requirements

You control the time and content planning of the RA

They work strategically with the local partners and internal interfaces to obtain/maintain an admission

You conduct and coordinate self-recurring re-registration projects until you obtain the authorisation

You create reports on the status of registrations as well as resource tracking and pre-planning for the relevant and new projects

In close consultation with the relevant project management

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

extensive experience in Regulatory Affairs in medical technology or comparable areas in the handling of standards, laws and regulatory requirements

well-founded knowledge of regulatory requirements e.g. Bsp.: CE, FDA, NMPA, Health Canada

very good knowledge of MS Office and common software tools and ERP systems

pronounced analytical skills combined with creativity and intuition

commitment and willingness to design as well as strong communication and organisational capabilities in an international environment

Moderation and establishment of relationships with different stakeholders, including external partners and regulatory authorities

independent and solution-oriented operation

active project management experience and knowledge of economic relationships

knowledge of English and good knowledge of German in word and writing; further foreign language is advantageous

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