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Fresenius Medical Care North America Regulatory & Quality Compliance Manager (m/f/d) in Waltham, Massachusetts

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

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