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.
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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.
In a context of innovation, growth and evolution of regulations on medical devices in Europe (MDR 2017/745) and internationally, we, as an essential ophthalmology actor, are recruiting to strengthen the Clinical Affairs department a:
Clinical evaluator / Medical writer (f/m/x) (fixed-term contract for approximately 15 monts)
This mission, with a broader scope than pure medical writing, requires exchanges with R&D, Regulatory Affairs, Marketing, etc. and will allow you to evolve on a daily basis in an international environment. You will focus on the following responsibilities:
Your Role
* Maintenance of clinical documentation to ensure the compliance of our products with applicable regulations through the clinical evaluation process for specific regions or countries (e.g., EU, China)
* Adaptation of protocols and bibliographic research, clinical evaluation plans, and clinical evaluation reports, considering the state of the art
* Participation in the monitoring of market surveillance for medical devices (PMS) in collaboration with various partners (R&D, QM, AR) to actively track and regulate the risk-benefit ratio throughout the lifecycle of existing medical device families
* Supporting an experienced colleague and contributing to the clinical evaluation strategy necessary for the approval of products under development, as well as participating in the creation of associated documentation
* Compiling knowledge about the medical device and understanding its application (comprehensive technical knowledge, usability, etc.) to establish a list of clinically relevant issues (CRIs)
* Presenting solutions to any IRC through adequate scientific reporting in the clinical evaluation report
* Managing the writing of scientific literature/documentation such as bibliographic summaries and other scientific documents created at the request of marketing or research and development
* This position requires you to familiarize yourself and integrate into the team at the La Rochelle site, but subsequently a home office agreement can be established, with regular travel to La Rochelle OR at our location in Berlin, Germany
* A degree from a college or university (e.g., Bachelor's), preferably in Life Sciences, Engineering, or Pharmacy
* Familiar with critical reading and evaluation of clinical documentation (publications, clinical study reports, etc.) as well as the interpretation of clinical data
* Experience in writing regulatory dossiers for notified bodies or health authorities and proven experience in medical writing
* Demonstrable analytical thinking and writing skills
* Initial knowledge of the relevant regulatory requirements for clinical evaluations of medical devices (MDR, MDCG, MEDDEV, IMDRF guidelines)
* Fluent in English both spoken and written, with German or French being an advantage
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