Head of Regulatory and Clinical Affairs (RA/CA) Focus Retina Operation Microscopes (OPMIs) (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.

In your product area, you drive and develop Regulatory Affairs and Clinical Affairs (RA/CA) strategy in the sense of RA mission and vision

You guide, coach and promote your team in accordance with the ZEISS Leadership principles, live these values and set goals

You are responsible for the strategy for international authorisations and support your team against the background of changing regulatory requirements

They are responsible for the budget, the planning, execution and maintenance of global product registrations and increase and optimize their efficiency and minimise transit times

They develop and implement the definition and planning of the clinical strategy (CA) for international approvals with the focus EU, CN, US; JP; KR

Ensure adequate, current, clinical evidence for the assigned products

They act as a responsible person in cooperation with internal partner teams and stakeholders at local and global level, with the aim of advancing the optimization and implementation of the RA and CA product lines processes and global process optimizations

You agree to the necessary strategies with local RA/CA Sales Service Centers (SSC) and act as strategic contact for launches and admissions

They support the cross-cutting, strategic and organizational development of RA/CA with the other product lines and their teams locally and globally.

You present your area in internal votes and Upper Management meetings and answer the corresponding reporting

They communicate with the designated body and authorities (global, in particular US FDA and Chinese NMPA)

completed university studies (a technical, economic, business or comparable course of study; at least 4 years)

many years of professional experience within a more complex regulatory/clinic area of a company (medical technology)

well-founded expertise in the international product registration of medical devices from classes I to III

Experience in leadership, motivation and sustainable development of a team within a larger organizational structure

lived decision-making skills based on entrepreneurial thinking and economic approaches

Experience in targeted communication with authorities and external representatives

Competence and fun and cooperation with international and intercultural teams

Experience in cooperation and accurate moderation with different stakeholders across all areas and hierarchy levels

fundamental understanding of regulatory compliance

basic understanding of processes and digitalization in medical technology as well as the Operational Excellence approach with the corresponding tools

English and fluent German skills

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