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

Fresenius Medical Care North America Regulatory & Quality Compliance Manager (m/f/d) in St. Wendel, Germany

Ihre Aufgaben

• 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, 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

Ihr Profil

• 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 GermanStructured and independent way of workingStrong communication skills*Ability to work in and with a team

• Assertiveness