Regulatory Affairs Manager (m/w/d)

Job title:

Regulatory Affairs Manager (m/w/d)

Company:

Fresenius Medical Care

Job description

Support product registrations, provide design input and assess changes to ensure regulatory product availability on global markets as per In-Center commercial strategy.TasksObtain and sustain global registrations for In-Center product portfolio as per Regulatory Strategy and product roadmapCompile Global Registration File per product and customise/ supplement in preparation of local submission where necessaryCommunicate / 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 registrationsProvide 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 documentsDetermine and maintain relevant criteria and on that basis assess design and process changes, initiate local evaluation of potential regulatory impact as appropriate, monitor local feedbackSupport global agency audits e.g., by FDA, NMPA, INMETRO and audits by Notified BodyInitiate production transfer after registration approvalPerform tasks relevant to the Quality Management System e.g., CAPAPrepare regulatory documentation required for tender proceduresRequirementsCompleted 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.LanguagesEnglish, written and oral, preferably competence level C1-2, minimum B2German optional

Expected salary

Location

Palazzo Pignano, Cremona

Job date

Fri, 10 Jan 2025 00:23:18 GMT

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