Expert Medical Systems Products Drugs

About the role

Systems, Quality & Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care’s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post-market surveillance, and promoting continuous improvement and system harmonization.

What you'll do

• Compilation and update of drug dossiers with focus on the clinical part in close alignment with the therapy field director
• Provide answers to authorities on registration related medical/pharmacological questions in close alignment with the director of the respective therapy field and with…
• Support of drug development projects
• Supportive function in risk management, in particular concerning medico-regulatory topics: Provide support in the development
• Participation in cross-functional teams for medical-regulatory aspects

What you need

• Clinical research
• Supply chain