Medical Device/ Drug Compliance
vor 1 Monat
Under the responsibility of the Lead Medical Device /Drug Compliance, Quality and Risk in the Design Control and Product Center “Concentrates and Disinfectants” department a new position is proposed:
Medical Device Compliance (Senior) Expert (m/f/d) you will be responsible for maintaining product compliance and preparing as well as coordinating product compliance in accordance with the relevant regulations.
Your task:
Preparation and maintenance of the Technical Documentation/Regulatory documentation Management of technical documentation and STED requests Perform Regulatory activities to maintain/receive product compliance e. g. implementing (new) laws/regulations and changes Creation and preparation of declaration of conformity Support Regulatory Affairs and Sustaining Center projects from regulatory perspective, execution of change tasks Preparation of Instructions for use and labeling materialsYour profile:
University degree with an engineering, scientific or technical background Experience in Regulatory Affairs in a pharmaceutical or medical environment Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 2017/745, MDSAP etc.) Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR §, etc.) Knowledge of sterilization processes, clean room requirements and of validation methods are advantageous IT user skills in MS Office (QTARK or PDM systems are an advantage) Fluent in English and German (written and spoken)Our offer for you:
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 have - for your professional future with meaning:
The opportunity to work remotely Whether in front of or behind the scenes - you will help to make better medicine accessible 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 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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