Junior Intl Regulatory Specialist - Med Tech (Maternity)

Orthofix; Bussolengo; On-site; EUR 30,000 - 35,000; Full time

Benefits offered by this job

Pension Fund

Health Insurance

Canteen

Training & development

Wellbeing initiatives

Social events

Job summary

Orthofix is seeking a Junior International Regulatory Specialist to join the Regulatory Affairs team in Bussolengo (Verona) on a maternity substitution contract. You will collaborate with Regulatory International area and RA Administrative specialist to ensure international product registrations are compliant and submitted on time.

The role requires English and Italian proficiency, a technical degree, and the ability to work with multiple internal and external stakeholders across regions.

Qualifications

• Technical degree required.
• Experience in regulatory affairs for medical devices is preferred.
• Strong English and Italian language skills (written and spoken).
• Knowledge of MDR and other major regulations is a plus.
• Ability to coordinate with multiple stakeholders and teams.

Responsibilities

• Ensure regulatory documentation for new or modified products is up to date for international registrations.
• Provide timely status updates on regulatory submissions to update files/databases.
• Prepare and maintain updated Procedure Pack Files.
• Support daily regulatory activities as directed by Regulatory Manager.
• Maintain up-to-date international data bases (e.g., Eudamed, UDI).
• Assist during audits/inspections by Notified Bodies or authorities.

Skills

Regulatory knowledge

English & Italian

Organizational skills

Project management

Team collaboration

Education

Technical degree

Job description

Orthofix is seeking a Junior International Regulatory Specialist to join the Regulatory Affairs team in Bussolengo (Verona) on a maternity substitution contract. You will collaborate with Regulatory International area and RA Administrative specialist to ensure international product registrations are compliant and submitted on time.

The role requires English and Italian proficiency, a technical degree, and the ability to work with multiple internal and external stakeholders across regions.