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 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. You prepare registration projects for new developments as well as changes

They independently analyze the requirements of international regulations and the application to complex products

They conduct RA managers professionally/laterally in their activities for other products (groups)

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 and business management, MarCom, international ZEISS locations (SSCs) & 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 estimate and develop risk mitigation measures involving time and economic factors

They plan multi-site projects (workflow or complex products), e.g. setting work packages, coordination with interfaces, creation of project plans and acquisition of project release

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 to obtain/maintain an authorisation.

They conduct and coordinate complex registration projects until the obtaining of the authorisation

They report the status of registration and initiation proactive alternative or additional solutions

Higher education in a technical, economic, business or comparable course

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

Project management experience

Embossed analytical skills combined with creativity and intuition knowledge of economic relationships and their strategic application

Very good knowledge of MS Office and common software tools

Intercultural competence and fun in exchange with global and diverse teams

Active stakeholder management at all levels

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

knowledge of English in word and writing;

German language skills desirable

readiness to travel regularly within Germany

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