Management of medical devices (Vision Care: contact lenses and care solutions; Ophthalmic Surgery: visualization equipment, irrigation solutions,viscoelastics, microinvasive surgery, etc.)

• Approval and coordination of the translation process for informational texts (“labeling”), including complex device documentation and packaging material approvals.

• Coordination with theGroßostheimaffiliate for all product-related activities.

• Support and lifecycle management of our medicinal products, in particular:

• Preparation and submission of variations, marketing authorization renewals, and PSURs

• Review of chemical-pharmaceutical topics and documentation, as well as

• Handling the resulting variation submissions

• Revision of packaging texts, including patient information leaflets and summaries of product characteristics

• In the case of product changes or discontinuations, cost-conscious coordination of packaging material stock depletion and product inventory sell-off timelines

• Coordination of the CCSI safety labeling update process: tracking and ensuring the implementation of safety-relevant information in the labeling texts of all products marketed in Germany. Monitoring compliance with KPIs based on monthly reports fromiMedidata

Clinicalinvestigations–medicaldevices

• Evaluation and submission of documentation for approval procedures and notifications of clinical investigations to the relevant competent authorities

• Handling ofsubsequentcorrespondence and deficiency letters

• Submission of amendments and notifications of study termination, including submission of final reports

• Review and approval of labeling drafts for clinical investigational samples

Marketing Support

• Ensuringaccurateproduct information in compendia such as RoteListe, Pharmindex, and theself‑medicationlist

• Regulatory review and approval of promotional materials, as well as verification of advertising claimsin accordance withlabeling, HWG, and UWG

• Handling regulatory and scientific inquiries, including customer requests

• Providing legal support for marketing projects

• Monitoring and interpreting legal requirements and official communications related to medicinal products, medical devices, food supplements, and cosmetics.Initiating resulting measures and implementing new processes.