Working Student - Product Regulatory Affairs

At Fresenius Medical Care, we are a global leader in kidney care, dedicated to improving the lives of patients with chronic kidney disease. Our mission is to provide high-quality and innovative products, services, and therapies across the entire healthcare continuum. Guided by our vision – “Creating a future worth living. For patients. Worldwide. Every day.” – we act with purpose and compassion, supported by a global team of more than 110.000 employees.

Our values define how we work

• We care for our patients, for each other, and for our communities
• We connect across teams and countries to achieve excellence together
• We are committed to doing the right thing – growing with purpose and advancing kidney care with integrity and innovation.

To support our Product Regulatory Affairs team (Concentrates), we are looking for a motivated Working Student (m/f/d) who is eager to gain hands-on experience in international medical device registration and regulatory compliance.

Your responsibilities

You will actively support the Product Regulatory Affairs Concentrates team   in an international environment, including:

• Contributing to the preparation and updating of global and country-specific registration dossiers for medical devices
• Supporting registration activities using internal regulatory tools in alignment with the established Registration Roadmap
• Preparing regulatory documentation and declarations required for market registrations
• Assisting in regulatory impact assessments related to product registrations

In addition, you will support the Product Regulatory Affairs Concentrates team in the context of the implementation of the Medical Device Regulation (MDR), including:

• Updating technical documentation in accordance with MDR requirements
• Reviewing labeling to ensure compliance with European and international medical device regulations (e.g. MDD, MDR)

Further responsibilities include

• Coordination and execution of international certification processes (e.g. Free Sale Certificates)
• Coordination of certification and legalization processes for international documents
• Statistical analysis and evaluation of registration data using internal tools

Your Profile

• Enrolled student (m/f/d) in Life Sciences, Regulatory Affairs, Biomedical Engineering, Pharmacy, or a related field
• Strong attention to detail and structured working style
• Interest in international regulatory requirements and medical device compliance
• Good analytical skills and confidence in handling data
• Fluent in German and English; additional languages are a plus

Start:  as soon as possible

Working hours:  20h/week

Location:  St. Wendel

We are committed to diversity and equal opportunities and welcome applications from people with disabilities.

Please upload your CV as well as your certificate of enrollment and, if applicable, a cover letter. If you indicate a severe disability, we kindly ask you to include appropriate proof with your application.