International Regulatory Affairs Associate – Junior

Orthofix Holdings, Inc.

Verona, Bussolengo

On-site

EUR 30,000 - 35,000

Full time

9 days ago

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Benefits offered by this job

Training opportunities

Competitive rewards

Canteen benefits

Wellbeing programs

International work environment

Job summary

Orthofix Holdings, Inc. in Verona, Italy, is seeking a Junior International Regulatory Specialist on a maternity substitution contract. The role reports to the Regulatory Affairs Manager and collaborates with international RA teams to ensure compliant product registrations and licenses.

Requirements include a technical degree and 1 year in a similar role, with fluency in English and Italian. Knowledge of MDR and broader regulatory frameworks is essential; strong organizational and analytical

Qualifications

Technical degree required; 1 year in a similar role, preferably in a Medical Device company.
Proficient in English and Italian (written and spoken).
Knowledge of European MDR.
Knowledge of other regulations (U.S., Japan, Canada, Latin America, Middle East, India, Asia-Pacific) is a plus.

Responsibilities

Ensure regulatory documentation for International product registrations is updated.
Provide timely regulatory submission information to update files and data systems.
Prepare and maintain up-to-date Procedure Pack Files.
Support the Regulatory team in daily regulatory activities as directed.
Maintain UpToDate International databases (e.g., Eudamed, UDI).
Assist during audits/inspections by Notified Bodies or Competent Authorities.