Specialist Regulatory Affairs (m/f/d)

For our location in Sexau we are looking for a Specialist Regulatory Affairs (m/w/d) for quality and approval management.

Examination, updating and maintenance of the technical documentation of medical devices for worldwide approval Responsibility for compliance and implementation of applicable regulatory requirements (FDA: 21CFR Part 820, MDR 2017/745, EN ISO 13485) Compilation of conformity assessment documentation Contact person for regulatory issues from development and production in the context of new product developments and product changes Coordination of cross-functional teams within the Erbe Group as part of global approval projects

Successfully completed technical training with a further training to the technician or successfully completed technical or scientific studies, ideally with medical technology or comparable qualification Ideally, first professional experience in quality/accreditation management in medical technology Good knowledge of QM systems (FDA: 21CFR Part 820, MDR 2017/745, EN ISO 13485) Good knowledge of regulatory standards in medical technology (EN 60601, EN ISO 14971, EN 62366-1, EN 62304) English fluent High sense of responsibility and a structured and analytical way

Start-up culture, open and creative team Flat hierarchies, collegial atmosphere and quick decision-making Flexible working hours Enrolment programme and appropriate training Cycling leasing Company fitness