[rif. d20623822] Regulatory Affairs Manager (m/w/d) - Fresenius

Support product registrations, provide design input and assess changes to ensure regulatory product availability on global markets as per In-Center commercial strategy.

• Obtain and sustain global registrations for In-Center product portfolio as per Regulatory Strategy and product roadmap
• Compile Global Registration File per product and customise/ supplement in preparation of local submission where necessary
• Communicate / collaborate with relevant interfaces e.g., In-Center Product Centers and Value Streams, SYSQARA Regulatory Affairs and Registration Centers of Verticals Home and CC&V.
• Perform site registrations
• Provide regulatory design input as per available information from SYSQARA functions as well as submission strategy guidance to sustaining and development project teams in In-Center Value Streams to ensure creation of approval-relevant documents
• Determine and maintain relevant criteria and on that basis assess design and process changes, initiate local evaluation of potential regulatory impact as appropriate, monitor local feedback
• Support global agency audits e.g., by FDA, NMPA, INMETRO and audits by Notified Body
• Initiate production transfer after registration approval
• Perform tasks relevant to the Quality Management System e.g., CAPA
• Prepare regulatory documentation required for tender procedures

Requirements

Completed studies in a scientific/technical field or comparable training with professional experience.

Minimum 1 year of professional experience in the field of Regulatory Affairs, Quality Management or other related Research and Development functions.

• English, written and oral, preferably competence level C1-2, minimum B2
• German optional