Expert Regulatory Information Management
vor 1 Monat
Your Tasks:
Definition, maintenance and further development of processes to ensure regulatory compliant approval of FME medical devices worldwide Creation and provision of regulatory documents for the global registration of FME medical devices Consulting and supporting all involved parties in the global registration of FME medical devices to ensure timely access to all relevant markets Planning, documenting, monitoring, reporting and tracking of projects in the RIM (regulatory information management) area Provision of information on regulatory status (registrations) for all FME medical devices Implementation and maintenance of a regulatory information management system (RIMS) including a process to steer and control registration activities world-wide (e.g., workflow-based) in accordance with pre-agreed roadmaps Support Verticals (business units) by creating and provisioning central documents needed for registrations including notarization, apostillation or embassy certifications
Your Profile:
Master in engineering or natural science Professional experience (> 5 yrs) in internationally acting companies; thereof min. 3 yrs. in the medical device industry in the area of regulatory affairs or quality management Excellent stakeholder management and communication skills, supporting transparent dialogue without avoiding conflicts ability to present and explain complex subjects convincingly to stakeholders from all levels Willingness to continuously learn and adapt to changing environments Strong expertise in RA and global regulatory requirements Comprehensive experience and proven track record in handling new developments, product registrations and maintenance of products Strong project management skills, highly structured and systematic working style Excellent knowledge of FME business and products ability to interact with all management levels to influence positive change Fluent in business English Additional language skills are a plus, e.g. German Willingness to travel in the scope of meetings, workshops, conferences, etc. 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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