Global Regulatory Specialist – Medical Devices (EU/US)

O; Verona; On-site; EUR 43,000 - 45,000; Full time

Benefits offered by this job

Smart working model

Canteen

Pension Fund - Health Insurance

Wellbeing initiatives

Job summary

Orthofix in Bussolengo (VR) seeks a Senior International Regulatory Specialist to lead global regulatory submissions and ensure compliance with EU MDR and US FDA requirements. You will prepare and maintain up-to-date regulatory Product Applications Files, collaborate with Quality, R&D and Commercial teams, and support inspections and registrations across international markets.

The role is full-time, on-site with a competitive salary package and benefits, offering the chance to work with a

Qualifications

• Technical degree and 5+ years in regulatory role, preferably in a Medical Device company.
• Deep knowledge of international standards and regulations (FDA CFR, EU MDR).
• Experience with regulatory submissions and registrations across international markets.

Responsibilities

• Prepare and maintain international product registrations and licenses.
• Collaborate with QA and R&D to ensure regulatory documents are complete and compliant.
• Support inspections and audits (FDA, NB, regulatory agencies).
• Manage regulatory changes in Oracle system and ensure timely updates.
• Prepare Free Sales Certificate and international documents for legalization.

Skills

Regulatory Affairs

Project Management

FDA CFR

EU MDR

Oracle PLM

Education

Technical degree

Tools

Oracle PLM

Job description

Orthofix in Bussolengo (VR) seeks a Senior International Regulatory Specialist to lead global regulatory submissions and ensure compliance with EU MDR and US FDA requirements. You will prepare and maintain up-to-date regulatory Product Applications Files, collaborate with Quality, R&D and Commercial teams, and support inspections and registrations across international markets.

The role is full-time, on-site with a competitive salary package and benefits, offering the chance to work with a