Regulatory Affairs Manager, Fokus Surgical Posterior Segment (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.

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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 admission projects for medical devices and undertake their time and content planning, taking into account the analysis of the regulatory requirements of international regulations

You work in development and change projects to ensure early consideration of regulatory requirements and their possible implementation

You develop licensing strategies for markets with complex registration requirements (such as Europe, USA, China, Russia, Saudi Arabia) in coordination with stakeholders such as product managers and business managers and implement them independently

You conduct and coordinate complex licensing projects and carry them through to obtaining the authorisation, carry out processes and implement shared possibilities for improvement

You carry out training for employees in their own field and support the development of further training documents for the further training of RA - colleagues and partner teams

You have a successful university degree in a technical, economic, business or comparable degree course

You have several years of experience in Regulatory Affairs in medical technology or comparable professional experience

You have experience in handling and applying the relevant standards, laws and regulatory requirements

You have very good knowledge of regulatory requirements for CE, FDA, NMPA, Health Canada, etc.

You have project management experience in larger structures

It distinguishes commitment, organizational and design will, combined with an independent and solution-oriented approach

It provides good communication with different stakeholders, including external partners and regulatory authorities in an international environment

You possess distinct analytical skills combined with creativity and intuition and understanding of economic relationships

You have knowledge of English in word and writing; another foreign language is advantageous

You have very good knowledge of MS Office and common software tools