Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people.
In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.
Join us today. Inspire people tomorrow.
Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.
Apply now! It takes less than 10 minutes.
- Responsibility for registration projects for non-active medical devices in ophthalmology. A big focus of your tasks will be the US market.
- Prepare registration projects for non-active medical devices in the field of ophthalmology by analysing requirements from international regulations that are relevant for approval, examining and evaluating implementation options with relevant stakeholders and independently deriving approval strategies
- Planning, managing and controlling complex registration projects; implementing concepts and planned actions and ensuring approval
- Participate in international projects for new registrations, registration of product changes or changed requirements triggered by changes in regulations
- Participate in development projects and change committees on approval-relevant issues and specify normative and regulatory requirements
- Continuously analyse and optimise RA processes working together with, e.g. Quality Management, Global Regulatory Affairs, Clinical Affairs, in order to improve procedures or adapt them to new regulations
- Work in an international team of Regulatory Affairs Managers who, together with Branding, Business Management and Logistics, ensure the market availability of our products
- University degree in a technical, economic, business or comparable field
- Knowledge of the regulations for medical devices with a focus on the US and related international standards
- Business fluent in English
- Several years of experience in the field of regulatory affairs, in medical technology or comparable
- Knowledge of the regulations for medical devices with a focus on Europe and the US and related international standards
- An analytical, systematic and goal-oriented approach
- Experience in project management
- Team spirit and good communication skills
- Experience in solving complex tasks in a matrix organisation
Wir bieten For 170 years, ZEISS has embodied a pioneering spirit and a pragmatic approach. ZEISS offers its employees a modern working environment, above-average benefits and a host of opportunities for further development.