Change Expert Regulatory Compliance (m/f/d) - Sterile Fluids - Bad Homburg, Germany

• Support of Product Center Sterile Fluids in cross-location activities to monitor product quality
• Participation in new component / product development activities as part of Cross Functional Team, related to risk analysis activities and for providing regulatory expertise
• Participation in risk management activities as team member for product risk analysis if applicable (participation for products, components, process in case of a design change)
• Support creation/maintenance of risk evaluation documents for medicinal products or medical devices
• Participation in regular quality meetings and preparation of relevant documentation
• Support harmonization activities of Product Center Sterile Fluids

Main Responsibilities:

• Leading regulatory or compliance changes change projects as project manager or supporting as team member for design change and compliance projects
• Project management for the implementation of change projects to comply with regulatory requirements
• Management of global teams within change projects
• Expert and interface function to the development department, marketing, production, quality department, as well as to the regional/local approval unit
• International coordination and communication in a global organization
• Supporting the department in cross-site activities to monitor product quality and regulatory compliance

What we expect?

• Successfully completed technical or scientific studies
• Experience in project management respectively change control process
• Experience in regulatory affairs or in a quality environment, ideally in a pharmaceutical/medical environment of advantage
• Knowledgeable in relevant regulations (such as registration of medicinal products, change control, GxP, EU requirements, NMPA regulation, US FDA requirements, ASEAN, etc.)
• Language requirements: Fluent in English, advanced in German•Structured and independent way of working•Strong communication skills•Ability to work in and with a team
• Assertiveness

Our offer to you:

There is a lot for you to discover at Fresenius, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:

• The opportunity to work on a mobile basis
• Whether in front of or behind the scenes - you will help to make better and 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, not the fastest, solution together
• 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

Please note that the offered role is currently limited to approx. 18 months.