Expert Regulatory Information Management (m/w/d)

at  Fresenius Medical Care

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.

• 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