Clinical Evaluator M/F

Trust something new, grow beyond itself and redefine the boundaries of the feasible. That is exactly what our employees can and should live daily. To make a sign with our innovations and to enable great. Because there are a lot of fascinating people behind every successful company. In an open and modern environment with numerous development and further training opportunities, ZEISS employees work in a culture characterised by expert knowledge and team spirit. All this is supported by the special ownership structure and the long-term goal of the Carl-Zeiss Foundation: to advance science and society together. Today dare. Inspire tomorrow. Diversity is part of ZEISS. We look forward to your application regardless of gender, nationality, ethnic and social origin, religion, world view, disability, age as well as sexual orientation and identity. Apply in less than 10 minutes.

In connection with innovation, growth and the elaboration of prescriptions for medical devices in Europe (MDR 2017/745) and globally, we are looking as a central actor in ophthalmology to strengthen the Department of Clinical Affairs:

Clinical evaluator / Medical writer (f/m/x)

This role, which goes far beyond pure medical writing, requires, among other things, an intensive exchange with R&E, Regulatory Affairs and Marketing and offers you the opportunity to develop daily in an international environment.

Your central responsibilities are:

Your role Maintenance of clinical documentation to ensure compliance of our products with the applicable requirements by the clinical evaluation process for certain regions or countries (e.g. EU, China). Adapting protocols and bibliographical research, clinical evaluation plans and clinical evaluation reports, taking into account the state of the art. Participation in the monitoring of the market for medical devices (PMS) in cooperation with the various partners (F&E, QM, AR) to actively track and regulate the risk-benefit ratio during the life cycle of existing medical device families. Support an experienced colleague and contribute to the clinical assessment strategy necessary for the approval of products in development and participate in the preparation of the associated documentation. Compile knowledge of the medical device and understand its application (ensuring technical knowledge, usability, etc.) to create a list of clinically relevant problems (CRIs). Presentation of solution approaches to each IRC by an adequate scientific presentation in the clinical evaluation report. Manage the writing of scientific literature/documentation such as bibliographical summaries and other scientific documents created on request by marketing or research and development. This position requires you to work in and integrate into the team at La Rochelle site, but subsequently a home office agreement can be set up with regular trips to La Rochelle OR at our location in Berlin.

University or university degree (e.g. Bachelor), preferably in Life Science, Engineering or Pharmacy. Consistent with critical reading and evaluation of clinical documentation (publications, clinical trial reports, etc) and with the interpretation of clinical data. Experience in the writing of regulatory dossiers for designated bodies or health authorities and proven experience in medical writing. Detection of analytical thinking and writing skills. Basic knowledge of relevant regulatory requirements for clinical evaluation of medical devices (MDR, MDCG, MEDDEV, IMDRF guidelines). Flowing English in Word and Writing, German or French of advantage JOBV1_EN