REGULATORY AFFAIRS OFFICER (F/M/D)

We are MIETHKE, a globally active, medium-sized medical technology company based in Potsdam. As a technology leader in the field of neurosurgical implants, we develop and manufacture highly specialized solutions for the drainage of cerebrospinal fluid - with precision, innovative strength and responsibility for our patients suffering from hydrocephalus. Our particularly high level of vertical integration is a key success factor.

As part of our Regulatory Affairs team, you will assist in coordinating and processing changes to our products, product information and production processes. You will help assess the regulatory implications of changes and update the technical documentation associated with them.

Be a part of our versatile team: Do you want to shape things, take on responsibility and work in an environment of equals? Then you've come to the right place. We are looking for a committed individual with analytical acumen, a structured way of thinking and a desire for responsibility.

And: diversity, appreciation and tolerance are part of our culture - we would be delighted if this also corresponds to your core values.

• You will assist with the tracking, coordination and documentation of requested and ongoing changes.
• You will support users in applying the system established at MIETHKE for the coordination and documentation of changes.
• You will help to ease the general workload of the change coordinators in their day-to-day operations.
• You will assist in reviewing changes with regard to regulatory and documentation requirements.
  You will work on the creation, maintenance and updating of technical documentation in the context of change management.
• You will research relevant regulatory requirements and standards and prepare them for use.

• Completed commercial, technical or scientific training or equivalent qualifications
• Initial experience in regulatory affairs, quality management or technical documentation is an advantage
• Interest in regulatory issues; a basic understanding of the requirements in a regulated environment is desirable
• A meticulous and independent approach to work, combined with strong organisational and teamwork skills and a clear, confident communication style
• Very good written and spoken German and English

• 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
• an employment relationship initially limited with a clear interest in a permanent contract in a secure economic situation
• the possibility of a company pension scheme, further qualification through the opportunity to participate in further training events
• sporting activities and team events as well as coffee specialties, tea and water at any time, but also much more