Global Regulatory Affairs: Junior Specialist (Maternity Cover)

Orthofix; Ne; On-site; EUR 28,000 - 36,000; Full time

Benefits offered by this job

Canteen

Health Insurance

Training and development

International environment

Job summary

Orthofix in Italy (Verona area) invites a Junior International Regulatory Specialist to join the Regulatory Affairs team. The role focuses on submissions, registrations, and maintaining compliance for international products.

You will collaborate with internal and external stakeholders, ensure timely data updates, support audits, and help maintain Eudamed/UDI databases. The contract is a maternity substitution; based in Bussolengo with standard working hours 8:30-17:30.

Qualifications

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

Responsibilities

• Ensure international product registrations are up to date for new or modified products
• Provide regulatory submission information status for the regulatory file platform
• Prepare and maintain updated Procedure Pack Files
• Support daily regulatory activities as directed by the Regulatory Manager
• Maintain UpToDate international data bases (Eudamed, UDI, etc.)
• Support during audits/inspections by Notified Bodies or authorities

Skills

Good English

Good Italian

Organizational skills

Problem solving

Education

Technical degree

Job description

Orthofix in Italy (Verona area) invites a Junior International Regulatory Specialist to join the Regulatory Affairs team. The role focuses on submissions, registrations, and maintaining compliance for international products.

You will collaborate with internal and external stakeholders, ensure timely data updates, support audits, and help maintain Eudamed/UDI databases. The contract is a maternity substitution; based in Bussolengo with standard working hours 8:30-17:30.