Regulatory Affairs Manager

2 giorni fa

Palazzo Pignano CR, Italia CH01 CHE Fresenius Medical Care (Schweiz) AG A tempo pieno

Regulatory Affairs Manager (m/w/d)
Support product registrations, provide design input and assess changes to ensure regulatory product availability on global markets as per In-Center commercial strategy.

Tasks

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.

Languages

English, written and oral, preferably competence level C1-2, minimum B2.

German optional.

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