Regulatory Affairs at Medtech-Startup in Munich
What we are doing
Mecuris develops software solutions that enable orthopaedic technicians and users to design individual
orthoses (splints) and prostheses (artificial limbs). For this purpose, we provide medical supply stores
with a digital workshop using the web-based Mecuris Solution Platform. Here, the orthopaedic technician
can digitally adapt medical products in form, function and design without prior 3D knowledge and then
manufacture them in a certified 3D printing center. In this way, we are enabling orthopaedic technology
experts to step into the digital age and together create a better quality of life for users.
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)
What we offer
> Startup culture & international team (we plan to internationalise in 2021)
> High personal responsibility for your role (and maybe others) & fast personal growth
> Flexible working hours & centrally located office in the heart of Munich (or remote work)
> Direct impact on improving quality of life for our users (patients)
Am Besten verweist du bei der Bewerbung darauf, dass du diese offene Position auf Startup Joblist gefunden hast.
Nutzen Sie jetzt die Möglichkeit individuelle Orthesen und Prothesen kosten- und zeitsparend online zu erstellen. Eingebunden in eine digitale Wertschöpfungskette sind wir Ihr Partner für die Zukunft in der Orthopädietechnik.