- Senior
- Bureau à Berlin
Seeing beyond - future of medical technology
For more than 100 years, ZEISS medical technology has been driving progress in ophthalmology and microsurgery. In ophthalmology, our solutions help to maintain and improve people's vision at every stage of their lives. In microsurgery, our solutions enable targeted interventions on diseased tissue so that small and sensitive organs continue to function optimally. Medical technology from ZEISS supports medical professionals in improving the lives of patients worldwide. The fact that our actions have a direct impact on people's well-being is what drives us every day.
Your Role:
Lead International Registration Projects: Spearhead cross-department initiatives for non-active medical devices in ophthalmology, spanning risk classes I to III. Analyze approval requirements and strategize implementation options, independently deriving registration strategies.
Drive Complex Approvals: Plan and execute complex registration projects, ensuring concepts and measures are implemented for successful approval.
Collaborate Across Sites: Engage in cross-site projects for new registrations, product modifications, or regulatory changes, ensuring seamless integration and compliance.
Optimize Regulatory Processes: Continuously evaluate and enhance Regulatory Affairs processes, working closely with departments like Clinical Affairs and Research & Development.
Join a Global Team: Be part of an international team of Regulatory Affairs Managers, collaborating with Business Management and Logistics to ensure product market availability.
Your Profile:
Educational Background: Hold a Master's degree or equivalent in business administration, engineering, or a related field.
Regulatory Affairs Expertise: Possess extensive experience in Regulatory Affairs within Medical Technology or similar industries, with strong project management skills.
Medical Device Registration Experience: Demonstrated experience in the registration of medical devices.
Analytical and Systematic: Approach tasks with an analytical, systematic, and goal-oriented mindset.
Matrix Organization Skills: Skilled in communicating and resolving complex tasks within matrix organizations.
Language Proficiency: Fluent in English; proficiency in additional languages is advantageous.
Your ZEISS Recruiting Team:
Nicole Kraft-Henzelmann Postuler maintenant