Head of Regulatory Affairs

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Head of Regulatory Affairs

Interested in a leading role with a company who are leading the way in digital healthcare? Want to support and strengthen a dynamic and collaborative team?

We're supporting a client in the medical device industry who are head-quartered in Hamburg and looking for a Head of RA to lead their interdisciplinary RA/QM team, working hands-on to help drive the success of the team.

Their focus is on digital healthcare solutions in several 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:

  • Oversee the team, enforcing the requirements of RAQM

  • Lead activities for successful entrance of product into international markets

  • Providing support during internal and external audits

  • Supporting and communicating with cross-functional teams such as R&D

Experience required:

  • Knowledge of ISO 13485 and experience with medical software and IEC 62304 is required

  • Experience with EU and FDA

  • Previous management/project leadership experience

  • 5+ 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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