Sachbearbeiter*in Regulatory Affairs (m/f/d)

We are MIETHKE, a global medium-sized medical technology company based in Potsdam. As a technology leader in the field of neurosurgery implants, we develop and manufacture highly specialized solutions for the derivation of brain water – with precision, innovative strength and responsibility for our patients suffering from hydrocephalus. Our particularly high production depth is a central success factor.

As part of our Regulatory Affairs team, you will support the coordination and processing of changes to our products, products and production processes. Working with you to evaluate the regulatory impact of changes and update the related technical documentation.

Be part of our versatile team: You want to design, take responsibility and work at eye level in an environment? Then you're right with us. We are looking for a dedicated personality with an analytical sense of shame, structure in thinking and lust for responsibility.

And: Diversity, appreciation and tolerance are part of our lived culture – we look forward to meeting your basic values.

You support the tracking, coordination and documentation of requested and ongoing changes. You support users in the application of the MIETHKE established system for coordination and documentation of changes. You provide a general relief for the change coordinators in the daily business. You support the review of changes regarding regulatory and documentary requirements. You work on creating, maintaining and updating the technical documentation in the context of change processing. You investigate relevant regulatory regulations and standards and prepare them.

completed commercial, technical or scientific training or comparable qualification first experience in Regulatory Affairs, quality management or technical documentation interest in regulatory issues; Basic understanding of requirements in a regulated environment desirable careful and independent functioning as well as organizational and team skills combined with a clear, sovereign communication very good knowledge of German and English in word and writing

a working environment in an innovative, medium-sized company with over 250 employees and interesting and varied tasks family-friendly and flexible working time models and a workplace where we can be ourselves a first fixed-term employment relationship with the clear interest in a period of grace for a secure economic situation Possibility of occupational pension provision, further qualification by the possibility of participation in training events sports offers and team events as well as coffee specialties, tea and water at any time, but also a lot more