Med Tech Regulatory Affairs Specialist — Technical Files

09 set - Bussolengo
Orthofix Holdings

Orthofix Holdings, Inc.
Tutti i candidati sono invitati a leggere attentamente la seguente descrizione del lavoro e le relative informazioni prima di candidarsi.
in Bussolengo (Verona) is seeking a Technical Product Regulatory Affairs Specialist to join our Regulatory Affairs team as a maternity substitution.

You will ensure availability of Technical Documentation File by maintaining EU MDR and FDA submission-ready files and coordinating with Quality Engineering and R&D.;
The role requires a technical degree xysqume and 3+ years in medical devices, strong English, and in-depth knowledge of US FDA CFRs and European MDR.

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