Regulatory Affairs Manager Focus Refraktiv (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 As a member of our Regulatory Affairs team, you play a central role in obtaining and maintaining market access for our innovative and established medical devices in key international markets (EU, USA, China and other MDSAP countries).

They support and support new development and product life cycle approval projects

They analyze international, regulatory requirements and their implementation in practical solutions as well as risk mitigation strategies for complex medical devices

They ensure that regulatory requirements are introduced early into development and change management processes

They work closely with cross-functional teams (F&E, Product Management, Clinical Affairs, Marketing, Sales/Service Center and Distributors) to evaluate and plan feasible action options

They develop and vote for admission strategies for key markets in cooperation with product and business managers

They implement approved admission strategies for markets with complex requirements and ensuring a timely, successful admission

They evaluate and interpret regulatory requirements, develop meaningful alternatives and ensure business-oriented implementation

You create, negotiate and extend registration documents yourself or in cooperation with internal teams, sales/service centers (SSC's) or sales partners

They work strategically with regional SSCs and internal contact persons to obtain and maintain authorisations

You plan, control and coordinate admission projects up to successful admission including reporting of project status

Completed university degree in engineering, natural sciences, economics or a comparable subject

Multiannual, practical experience in regulatory affairs within medical technology or comparable industries

Knowledge of regulatory framework conditions and authorisation procedures, in particular in the EU, the USA, China and other MDSAP countries

Good knowledge of clinical applications in the regulated environment

Detegratable experience in project management

Embossed analytical skills combined with creativity and healthy judgment

Safe handling of regulatory strategies and their economic/business assessment

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

High intercultural competence and joy in cooperation with global, multidisciplinary teams

Ability to set priorities, make decisions and manage complex tasks independently and organised

Very good oral and written knowledge of German and English

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