Today, we are setting new standards in digital urology to provide holistic care to patients seeking treatment and support the community on their road to recovery, both online and on-site. As a Senior Regulatory Affairs Specialist, you will work closely with all departments and be mainly responsible to prepare / review and maintain the technical documentation according MDR 2017/745 (EU) and preparation, review and maintenance as well as submissions for international approval. * Responsible for the creation, review and maintenance of technical documentation * Support and guidance of other department for Medical Software and Cybersecurity * Support Clinical Evaluation, Vigilance / Post-Marketing Surveillance activities * Support in the creation and handling of Information (IFU, Labels, Brochure, Website, UDI) * Support during audit (internal, external, MDSAP, etc.) * Support database entries (EUDAMED, DMIDS, GUDID, etc.)
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