Praktikant (m/w/d) Quality Management & Regulatory Affairs
Core
Support Quality Management and Regulatory Affairs teams with a focus on ERP system development and digital transformation processes.
Role type
Intern (Quality Management & Regulatory Affairs)
Builds
ERP system updates, regulatory documentation, and software validation artifacts
Domain
Medical device industry + Quality Management
Required skills
ERP system knowledge, software validation, data management, ISO 13485:2016 documentation, literature research, document translation
Preferred skills
Medical device industry experience, Quality Management experience
Technologies
ERP systems, Office suite (Word, Excel, PowerPoint)
Responsibilities
Assist in ERP system migration and business process optimization, support software validation per regulatory requirements, conduct and evaluate software tests, maintain and structure ERP data, create quality-related documents per ISO 13485:2016, compile technical documentation for international approvals, conduct literature research for clinical evaluation per MDR, translate documents into English
Seniority
Intern
