At the earliest possible date, we are looking for a
Working Student (m/f/d) Technical Documentation
Location Wiesbaden
Are you interested in gaining hands-on experience at the interface of Regulatory Affairs and Product Management? Do you have a strong eye for detail and enjoy working with structured, precise documentation? Then join our team as a Working Student in Technical Documentation and contribute your skills in the dynamic field of in vitro diagnostics (IVD).
WHAT YOU CAN EXPECT:
- Assist in the preparation, revision, review, and maintenance of technical and scientific documentation for IVD product files in compliance with IVDR (EU 2017/746), the IVD Directive, and other applicable regulatory requirements - ensuring the creation and maintenance of the Declaration of Conformity.
- Support the management of product documentation within the electronic document management system (eDMS), including workflow creation and coordination.
- Actively contribute to and coordinate tasks within projects such as IVDR implementation, development initiatives, and new product launches.
- Provide administrative and operational support in day-to-day business activities.
- Prepare process-related documentation and collaborate closely with internal stakeholders including Regulatory Affairs, Product Management, Clinical Affairs, and International Registration.
- Support operational workflows, including the provision of customer-relevant information to internal departments and, where applicable, external partners.
- Contribute to corrective actions and related processes as part of the ongoing maintenance of technical documentation.
- Review scientific reports, including the evaluation of product-specific analytical and clinical data and their interrelationships.