Regulatory Affairs Manager

Interested in joining a company who are leading the way in digital healthcare? Want to be a part of a dynamic and collaborative team?

We're currently supporting a client in the medical device industry who are head-quartered in Hamburg and are looking to strengthen their interdisciplinary RA/QM team. Their focus is on digital healthcare solutions in a number of areas including oncology, neuroscience and immunology, with plenty of further innovation in the pipeline.

Due to their flexible and adaptable culture, this role can be based remotely from anywhere in Germany!

Focuses:

The creation and maintenance of technical documentation
Support with successful entrance of product into international markets
Providing support during internal and external audits
Implementing new regulatory requirements in the Quality Management System

Experience required:

Knowledge of ISO 13485 and experience with IEC 62304 is desirable
2+ years of experience within Regulatory Affairs
Fluency in English and German.

If you're interested in this position, please contact Hollie Barry for further details: hollie.barry@adaptivelifescience.com

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