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 driving or improving product development processes in close collaboration with the therapy field director
- Planning and support of medico-scientific activities related to generation of clinical evidence (studies) in close alignment with the respective director and Clinical Research
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here represent those employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
EDUCATION:
University degree in Medicine, Pharmacy, natural science, medical engineering or related science
EXPERIENCE AND REQUIRED SKILLS:
- At least 5 years of work experience, preferably in a comparable position within health care or pharmaceutic or medical technology companies or research institutions
- Experience, preferably in the medical device business
- Knowledge of relevant regulations for medical devices (Medical Device Regulation, MDR)
- Competence in the direct compilation of medical and scientific documents, and in the coordination and collection of contributions from various people/departments
- Experience in conducting systemic and process-oriented research in medical and scientific databases
- Familiarity with relevant products and topics in the field of dialysis / nephrology
- Analytical intellectual capacity
- Self-motivated, responsible and structured working method
- Diligence and resilience
- Interactive and interdisciplinary approach
- Team player
- Good communicator
- Flexibility
- Good conflict resolution skills
- Inter-cultural competence
