Regulatory Affairs and Quality Manager Regulatory Affairs and Quality Manager
2 weeks ago
Senior Quality and Regulatory Affairs Manager
Permanent contract
Remote, office located in Berlin, Germany - Must travel on-site once a month
Are you an experienced QA Manager with experience in regulatory affairs and ISO?
They are a passionate team of visionaries and engineers looking to revolutionise med-tech, in particular linked to women health.
Though this position is remote, you will have to be able to travel to the Berlin office once a month, and therefore be in the EU area.
Take care of the implementation and maintenance of a Quality Management System (QMS) that complies with ISO 13485, ISO 14971, IVDR and FDA 510(k)
- Ensure that the processes and products meet all necessary quality and regulatory requirements before they reach the users
- (In English, though it could also be in German) Communicate with Notified Body and other responsible authorities
- Experience with regulatory affairs for medical devices and QMS
- Knowledge of, or experience with, in-vitro diagnostic medical devices regulation (MDD / MDR) IVDR and CFR
- Exceptional communication skills, attention to detail and project management experience or knowledge
Able to speak German to B1/B2 level
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