• Regulatory & Quality Compliance Manager (m/f/d)

    Fresenius Medical Center (Knoxville, TN)


    The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).**

    Main Responsibilities:

    + Support as regulatory expert development and new registration projects (Medicinal Products)

    + Project management for the implementation of projects to comply with regulatory requirements

    + Organization of submission-readiness of regulatory documentation (e.g., CMC relevant parts)

    + Organize and support global creation and maintenance of regulatory documentation

    + 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

     

    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, CMC, ICH M4, 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

    + Supporting the department in cross-site activities to monitor product quality and regulatory compliance

     

    EOE, disability/veterans