(Junior) Regulatory Affairs - Devices Specialist (m/f/d)
Fresenius Medical Center
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
Confirm your E-mail: Send Email
All Jobs from Fresenius Medical Center