Important: The position is limited to 18 months.

Your Responsibilities:

• Defining, maintaining, and continuously improving processes to ensure global regulatory compliance for the approval of FME medical devices
• 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 area
• Provision of information on regulatory status (registrations) for all FME medical devices
• Implementation and maintenance of a registration information management system (RIMS) including a process to steer and control registration activities worldwide (e.g., workflow-based) in accordance with pre-agreed roadmaps
• Support Verticals by creating and provisioning central documents needed for registrations including notarization, apostillation or embassy certifications

Your Profile:

• Minimum Bachelor in Engineering or Natural Science, Master is desirable but not mandatory
• 1-3 years of professional experience in internationally operating companies, including at least 1 year in the medical device industry within regulatory affairs or quality management
• Strong stakeholder management and communication skills, while continuously learning and adapting to changing environments
• Strong expertise in RA and global regulatory requirements
• Strong project management skills, highly structured and systematic working style
• Excellent knowledge of FME business and products
• Fluent in English, additional language skills (e.g., German) considered a plus
• Willingness to travel in the scope of meetings, workshops, conferences, etc.

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

A 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

• Defining, maintaining, and continuously improving processes to ensure global regulatory compliance for the approval of FME medical devices
• 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 area
• Provision of information on regulatory status (registrations) for all FME medical devices
• Implementation and maintenance of a registration information management system (RIMS) including a process to steer and control registration activities worldwide (e.g., workflow-based) in accordance with pre-agreed roadmaps
• Support Verticals by creating and provisioning central documents needed for registrations including notarization, apostillation or embassy certification