Expert Medical Systems Products

**PURPOSE AND SCOPE:**

Compilation of Clinical Evaluation Reports (CERs) and related documents in compliance with relevant regulatory laws and directives for all Fresenius Medical Care’s and affiliates. With these and related documents, efficacy and safety shall be proven to obtain product registrations and to evaluate the clinical application of products already in the market.

**PRINCIPAL DUTIES AND RESPONSIBILITIES:**

+ Authorship of CERs and related documents in close alignment with the director of the respective therapy field
+ Supportive function in risk management, in particular concerning medico-regulatory topics: Provide support in the development, maintenance and updating of documents related to risk management deliverables
+ Participation in cross-functional teams for medical-regulatory aspects
+ Authorship of assessments concerning product development issues, in analysis of clinical data and in defining the medical evidence needed for driv...