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
Career with a purpose
Inclusion and diversity
Stability
Learning and development
Local benefits
Work-life balance
At a glance
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We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly.
We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results.
We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day.
We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.
What we stand for
Empowering people. Advancing care. Inspiring with our purpose and values.
Everything we do here is about making people’s lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.