Plan, create and update technical documentation and assume responsibility for medical device and development files.
to be responsible for the risk management of our medical devices and to ensure regulatory compliance throughout the entire product lifecycle.
Prepare, coordinate and be responsible for applications and change notifications for notified bodies and authorities.
As the central contact person for regulatory issues, you will work in an interdisciplinary manner and also pass on your knowledge internally.
You're the best fit for us if you...
You have a technical or scientific degree, e.g., in medical technology, mechanical engineering, plastics engineering or engineering sciences, or a comparable qualification.
You have initial professional experience in the field of Regulatory Affairs of a medical technology company as well as knowledge of medical device law (Medical Device Regulation), technical documentation and DIN EN ISO 13485.
You are characterized by a structured and independent way of working and you maintain an overview even in complex regulatory matters.
You are proficient in MS Office and ERP systems and have fluent German and English skills (C1).
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