Change Expert Regulatory Compliance
Vor 7 Tagen
Main Responsibilities:
Leading regulatory or compliance changes change projects as project manager or supporting as team member for design change and compliance projects Project management for the implementation of change projects to comply with regulatory requirements Management of global teams within change projects Expert and interface function to the development department, marketing, production, quality department, as well as to the regional/local approval unit International coordination and communication in a global organization Supporting the department in cross-site activities to monitor product quality and regulatory complianceWhat we expect?
Successfully completed technical or scientific studies Experience in project management respectively change control process Experience in regulatory affairs or in a quality environment, ideally in a pharmaceutical/medical environment of advantage Knowledgeable in relevant regulations (such as registration of medicinal products, change control, GxP, EU requirements, NMPA regulation, US FDA requirements, ASEAN, etc.) Language requirements: Fluent in English, advanced in German•Structured and independent way of working•Strong communication skills•Ability to work in and with a team AssertivenessOur offer to you:
There is a lot for you to discover at Fresenius, 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 opportunity to work on a mobile basis Whether in front of or behind the scenes - you will help to make better and 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, not the fastest, solution together 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 companyPlease note that the offered role is currently limited to approx. 18 months.
Support of Product Center Sterile Fluids in cross-location activities to monitor product quality Participation in new component / product development activities as part of Cross Functional Team, related to risk analysis activities and for providing regulatory expertise Participation in risk management activities as team member for product risk analysis if applicable (participation for products, components, process in case of a design change) Support creation/maintenance of risk evaluation documents for medicinal products or medical devices Participation in regular quality meetings and preparation of relevant documentation Support harmonization activities of Product Center Sterile Fluids 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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