Regulatory Affairs Manager, Medical Device

Medical Device Regulatory Affairs Manager

Based: Leopoldshöhe

The company is a global leader in the Genomics market. They offer a range of Instruments and services which include DNA Sequencing, next-generation sequencing, and Medical Devices. The customers are predominately in the biotechnology, pharmaceutical and other scientific markets.

The Role:

Office based to begin with but once training and after time in the position hybrid working will be available. 10 % travel at most and this will be for training and support.

An important part of the position is the evaluation of RoHS / REACH conformity in connection with biocompatibility.

The maintenance of the technical documentation according to MDR specifications is another core task of this position.

You will also co-ordinate with distributors to make sure the products they are selling is up to regulation in each region. There will be work on non-EU regulations, but full training will be provided on this. 

The requirements:

Fluent English and German are required.

Proven experience in the field of regulatory affairs in medical/scientific technology.

Knowledge of national and international regulations relevant to regulatory affairs

Educated to degree level or further in Technical / Scientific Studies (electrical engineering, medical technology, mechanical engineering, Molecular Biology, Biotechnology)