Regulatory Product Maintenance Specialist – Med Tech

Orthofix

Bussolengo

In loco

EUR 30.000 - 35.000

Tempo pieno

6 giorni fa

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Descrizione del lavoro

Orthofix in Bussolengo (Verona) seeks a Junior Regulatory Product Maintenance specialist on a 1-year contract to join Regulatory Affairs. You will ensure that Product Technical documentation is current and compliant, coordinating with internal teams, consultants, and Notified Bodies.

The role requires a technical degree, English and Italian proficiency, and knowledge of MDR; travel is around 10% with a competitive salary range.

Competenze

Technical degree
1 year in a similar position preferably in a Medical Device Company
Good English and Italian, both written and oral
Knowledge of medical device European MDR; additional regulations knowledge is a plus
Technical knowledge of medical devices and company manufacturing processes

Mansioni

Maintain and update Regulatory Technical documentation (DMF) and indexes as needed.
Maintain UpToDate EU Product Technical Files and FDA Product Applications File for regulatory submissions on time.
Prepare and maintain updated Procedure Pack Files.
Support the Regulatory team in daily regulatory activities as directed by the manager.
Prepare and maintain UpToDate Product technical sheets in Italian and English.
Interface with Notified Bodies for updates to Technical Documentation Files.
Support international registrations documentation requests; assist labeling updates.
Travel up to 10%.