Regulatory Affairs Manager
vor 4 Wochen
In your role as Regulatory Affairs Manager (m/f/d) you will support product registrations, provide design input and assess changes to ensure regulatory product availability on global markets.
Your assignments:
Obtain and sustain global registrations for product portfolio as per Regulatory Strategy and product roadmap Provide Regulatory Strategy and product roadmap input as primary liaison to local and global product teams Compile global registration file (STED) per product and customize/ supplement in preparation of local submission where necessary Communicate / collaborate with relevant global interfaces Support site registrations and tender procedures Provide regulatory design input and submission strategy guidance to sustaining and development project teams to ensure creation of approval-relevant documentsYour profile:
Completed studies in a scientific/technical field or comparable training with professional experience Several years of experience in the field of Regulatory Affairs, preferably for medical devices in global markets Business proficient in English (written and spoken) Career with a purposeWe offer an opportunity to create and deliver treatments that save and change lives for the better. We’ll support your ongoing development. And you’ll be part of a dedicated team of people who inspire each other to create the best possible healthcare outcomes each and every day. Inclusion and diversityJoining Fresenius Medical Care means becoming part of a team that values diversity. We embrace the wealth of different backgrounds, cultures, experiences and opinions that make up our workforce and strive to create an inclusive atmosphere in which all our employees feel valued. StabilityDeveloping innovative products and continuously improving our renal therapies made us the clear market leader in the production of hemodialysis machines, with sustainable, profitable growth . This position provides our 125000 employees with the stability and security they need to help improve the lives of our patients. Learning and developmentWe offer participation in programs at world-class business schools, leadership development, regular training for our nurses, health care professionals and manufacturing staff and digital access to high-quality educational content for all employees worldwide 24/7. Local benefitsOur employees enjoy both local and global opportunities for growth and personal fulfilment. We offer local benefits designed to suit the requirements of the respective country and place of work to create ideal conditions everywhere. Work-life balanceWe want to empower people to deliver better care. Therefore, we promote a better work-life balance through flexible working hours, part-time models, the possibility to work from home, and more.-
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