Clinical Affairs Manager Microsurgery

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.

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Aufgaben
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 As a Clinical Affairs Manager (m/f/x), you will play a pivotal role in driving the clinical strategy for the international approval of complex new product developments and product improvements in the ZEISS microsurgery. You will be responsible for defining, planning, and executing all necessary clinical studies and projects worldwide and evaluating clinical data for product definition, registration, and marketing purposes.

• Definition and implementation of the clinical evaluation strategy for complex and challenging development projects focused on innovative microsurgical applications in the area of intra-operative visualization and digital imaging in neurosurgery
• Definition and oversight of the execution of required clinical studies and projects, including those conducted internationally and across multiple locations
• Responsibility for budget and timeline planning for the entire clinical strategy Oversight of statistical analysis and evaluation of clinical data
• Review and approval of product-specific marketing materials and publications
• Ongoing participation in multidisciplinary project teams involved in product development and product improvements, from initial product definition through to market launch.
• Support of Clinical/Regulatory Affairs teams worldwide in product registration efforts
• Responsibility for adapting and improving Clinical Affairs processes
• Regular interdisciplinary collaboration and leadership of cross-location projects in the field of Clinical Affairs

Profil

• Successfully completed a degree in a natural science or related field (e.g., Medicine, Medical Engineering), or possess a comparable qualification
• Several years of relevant professional experience in Clinical Affairs or Clinical Research within the medical device industry or with contract research organizations on medical devices
• In-depth knowledge of the regulatory requirements for clinical studies and clinical evaluations for medical devices, with proven experience and success in designing clinical studies
• Practical experience in project management and medical writing
• Strong analytical skills and creativity, combined with excellent communication abilities and organizational talent, particularly in an international environment
• Excellent written and spoken English and German
• Proficient in MS Office and commonly used software tools

Wir bieten
Important note
Please be advised that a valid work permit for Germany is required for non-EU citizens. Unfortunately, applications without a valid work permit and sufficient German language skills may not be considered.

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