Regulatory Affairs Expert, Digital Software Products (m/f/d)

Developing 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., 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.

Ihre Aufgaben

• Creation, maintenance, appoval and control of global regulatory product documentation (e.g. global technical documentation, registration files)

• Content creation, alignment and approval of instruction of use/SM/IGL/label

• Provide guidance and expertise to help with identification of relevant compliance standards and associated testing

• Align change notifications to notified bodies/authorities (with SysQaRa)

• Perform conformity assessments (nMD, MD and other Products)

• Preparation of technical part for clinical evaluation report

• plan

• Ensure regulatory product availability on global markets as per in-center commercial strategy

• Coordination of regulatory activities, alignment of regulatory strategy and roadmaps across the IC product groups

• Compile global registration file (STED) per product and customize/ supplement in preparation of local submission

• Preparation of free sale certificates and declarations for regulatory submissions

• Registration of medical devices, including trade goods and kits, as well as registration of manufacturing sites and new production lines

• Act as regulatory change project lead, 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. Proactive

  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. Reliable

  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. Excellent

  We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.

Ihr Profil

• Technical/engineering /scientific background (degree)

• Minimum of 1 year professional experience in the field of regulatory or quality assurance medical devices / medical products

• Knowledge in the field of development and/or manufacture and control of medical devices and medical products (2 years)

• Required: Office (Excel/Word/Power Point), additional: QTRAK, PDM systems as PTC Windchill, FMEA tools

Wir bieten Ihnen

There is a lot you can discover at Fresenius Medical Care, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:

• The option to work on a mobile basis

• Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world

• Individual opportunities for self-determined career planning and professional development

• A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one

• A large number of committed people with a wide range of skills, talents and experience

• The benefits of a successful global corporation with the collegial culture of a medium-sized company, We 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 benefits

Our 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 balance

We 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. Show all 6 services