Regulatory Affairs Specialist

Overview: As a Senior International Regulatory Specialist at Orthofix, you will play a pivotal role in ensuring the global product international regulatory submissions are completed on time, maintaining full compliance with all applicable global regulatory requirements and internal product/project goals.

About the Job: We offer an exciting opportunity to join our Regulatory Affairs team based in Italy. This position requires collaboration with Quality Engineering and R&D Departments to apply identified regulatory requirements for technical product documentation files.

Main Responsibilities:

• Program, prepare and maintain up-to-date international product/facility submissions
• Identify, plan and collect regulatory submission documents for international markets
• Verify domestic and international regulatory documents before product application registrations
• Provide timely regulatory information status to update the RAMS platform
• Contribute to preparing regulatory strategies for new/modified products

Requirements:

• Technical degree (5+ years) in similar position preferably in Medical Device Company
• Excellent English written and spoken required
• Deep knowledge of international standards and regulations
• Project management experience in PLM system Oracle

What We Offer:

• Friendly, warm, and innovative atmosphere
• Healthy, inspiring, and international work environment
• Training and development opportunities
• Smart working model (2 days per week)
• Competitive salary: €42,000-€45,000 per year

We Are Looking For: A skilled professional with excellent communication skills and problem-solving abilities to manage multiple projects simultaneously and prioritize tasks accordingly.