Clinical Affairs Manager Microsurgery (MCS) (m/w/x)

ZEISS; Deutschland; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading medical technology company in Germany is seeking a Clinical Affairs Manager to drive the clinical strategy for new product developments in microsurgery. The role involves defining, planning, and executing clinical studies globally, ensuring compliance with regulatory requirements. Ideal candidates have a background in natural sciences, extensive experience in Clinical Affairs, and strong communication skills in English and German.

Qualifikationen

• Several years of relevant professional experience in Clinical Affairs or Clinical Research.
• In-depth knowledge of regulatory requirements for clinical studies.
• Excellent written and spoken English and German.

Aufgaben

• Define and implement the clinical evaluation strategy for development projects.
• Define and oversee execution of required clinical studies.
• Participate in multidisciplinary project teams.

Kenntnisse

Analytical skills

Project management

Communication abilities

Organizational talent

Medical writing

Ausbildung

Degree in natural science or related field

Tools

MS Office

Jobbeschreibung

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.

Your Role

• 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

Your Profile

• 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

Your ZEISS Recruiting Team:
Jana Benn