Your responsibilities in our Operations Team

*As Regulatory Affairs Manager you take care of the approval of new products within our company. For this purpose, you are responsible for organising all measures necessary to obtain approval from national and international authorities for the development, manufacture, marketing and sale of the products, which are not already covered by the Release Manager or the Risk Manager.

*As Quality Manager you ensure all products and services meet / exceed the customers’ expectations (medical & non-medical). You are also the guardian and final instance of the QMS.

*PRRC Quality: Quality responsible in 3 person team (besides Development + Production PRRC)

Your must-haves

*3+ years experience in Regulatory Affairs

*1+ years experience in Quality Management (ideally 13485)

*Experience in risk management (14971)

*Fluent English + German

Your nice-to-haves

*Experience with class I devices

*Experience with quality management & documentation for non-medical software

*Experience with clinical investigations

About Moyyn: Moyyn is AI based reverse job platform. Once you apply to the platform, you will be matched with several job offers from our clients and also get recommendations for various job offers. If the clients find your profile interesting, they will get in touch with you directly for interviews. Apply once to the talent pool and get interviews from many companies directly. We are recruiting candidates for this particular job as a recruiter for one of our partner platforms.