Quality Management Representative and Regulatory Affairs Specialist | Biologe (m/w/d)

Job Summary

VITROMED GmbH, a manufacturer of medical devices for Assisted Reproductive Technology (ART), is seeking a qualified Biologist or professional with a scientific/medical background to serve as a Quality Management Representative (QMB) and Person Responsible for Regulatory Compliance (PRRC). In this role, you will be responsible for maintaining and developing the quality management system at the Jena site, conducting internal audits according to ISO 19011, and managing external audit processes. Furthermore, you will act as the PRRC, ensuring product conformity, managing technical documentation, and overseeing Post-Market Surveillance (PMS) activities, including reporting to authorities and maintaining databases like Eudamed. This position is ideal for a detail-oriented professional who thrives in a highly regulated, multinational environment. You will play a critical role in ensuring regulatory compliance and quality excellence, working closely with a dedicated team of experts. The role offers the opportunity to contribute significantly to the company's growth while maintaining high standards in medical device production.