Junior Regulatory Product Specialist - MDR & Filings

Orthofix Holdings, Inc.; Verona; Hybrid; EUR 30,000 - 35,000; Full time

Benefits offered by this job

Canteen

Pension Fund & Health Insurance

Training and development opportunities

Job summary

Orthofix Holdings, Inc. in Bussolengo (Verona) seeks a Junior Regulatory Product Maintenance specialist on a 1-year temporary contract.

You will ensure regulatory documentation is up to date, maintain EU Product Technical Files, and support regulatory submissions in a global framework. You will collaborate with Regulatory Technical Product and RA Administrative specialists, interface with Notified Bodies, and help with leaflets, IFU updates, and labeling maintenance.

Qualifications

• Bachelor level or higher technical degree in a relevant field.
• Proficient English and Italian, both written and spoken.
• Knowledge of medical device European MDR and related regulatory knowledge is a plus.
• Analytical mindset with ability to interpret regulatory data and trends.
• Experience in project management and coordinating across teams.

Responsibilities

• Maintain Regulatory Technical Files in line with MDR and other regional requirements.
• Update EU product Technical Files and FDA product applications in collaboration with departments.
• Prepare and maintain up-to-date procedure packs and labeling materials.
• Support daily regulatory activities and coordinate with Notified Bodies.
• Liaise with internal teams, consultants, distributors, suppliers; travel approx. 10%.

Skills

Technical degree

English and Italian

Regulatory knowledge

Analytical approach

Project management

Education

Technical degree

Job description

Orthofix Holdings, Inc. in Bussolengo (Verona) seeks a Junior Regulatory Product Maintenance specialist on a 1-year temporary contract.

You will ensure regulatory documentation is up to date, maintain EU Product Technical Files, and support regulatory submissions in a global framework. You will collaborate with Regulatory Technical Product and RA Administrative specialists, interface with Notified Bodies, and help with leaflets, IFU updates, and labeling maintenance.