Junior Regulatory Documentation Specialist

Orthofix Holdings, Inc.; Bussolengo; In loco; EUR 30.000 - 35.000; Tempo pieno

Vantaggi offerti da questo lavoro

Canteen

Health insurance

Wellbeing program

Training opportunities

Social events

Descrizione del lavoro

Orthofix Holdings, Inc. in Bussolengo (Verona) is seeking a Junior Regulatory Product Maintenance specialist for a 1-year temporary contract. You will support the Regulatory Affairs team, ensuring EU MDR compliance across technical files and product leaflets.

The role involves collaboration with multiple departments, external partners, and travel up to 10%. Fluency in English and Italian is required, with a keen eye for regulatory detail.

Competenze

• Technical degree in a related field plus 1 year in regulatory roles.
• Familiarity with EU MDR and medical device regulations.
• Good command of English and Italian both written and spoken.

Mansioni

• Update and archive Regulatory Technical Documentation (DMF) and indexes for EU/FDA files.
• Collaborate with internal teams, Notified Bodies, consultants and suppliers for regulatory activities.
• Prepare and maintain UpToDate product technical sheets in Italian and English.

Conoscenze

English (written and spoken)

Italian (written and spoken)

Regulatory affairs

Medical devices knowledge

Project management

Formazione

Technical degree

Descrizione del lavoro

Orthofix Holdings, Inc. in Bussolengo (Verona) is seeking a Junior Regulatory Product Maintenance specialist for a 1-year temporary contract. You will support the Regulatory Affairs team, ensuring EU MDR compliance across technical files and product leaflets.

The role involves collaboration with multiple departments, external partners, and travel up to 10%. Fluency in English and Italian is required, with a keen eye for regulatory detail.