Regulatory Product Maintainer – 1-Year Contract

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

Benefits offered by this job

Competitive reward packages

Canteen

Wellbeing initiatives

Job summary

Orthofix in Bussolengo (Verona) seeks a Junior Regulatory Product Maintenance specialist to join Regulatory Affairs on a 1-year temporary contract. You'll collaborate across departments to keep Product Technical documentation compliant and up to date, supporting international registrations and labeling updates.

The role requires a technical degree, 1 year in a related medical device setting, and strong English/Italian language skills. Travel ~10% expected.

Qualifications

• Technical degree required.
• 1 year in a similar position, preferably in a Medical Device company.
• Good English and Italian, both written and oral.
• Knowledge of Medical Device European MDR and related regulations.
• Technical knowledge of medical devices and company manufacturing processes.

Responsibilities

• Ensure Regulatory Technical documentation is updated and archived in the Technical File (DMF).
• Maintain EU Product Technical Files and FDA Product Applications Files up-to-date.
• Prepare and maintain updated Procedure Pack Files.
• Support daily regulatory activities as directed by Regulatory Manager.
• Prepare and maintain UpToDate Product technical sheets in Italian and English.
• Interface with Notified Body for Documentation updates.
• Support international registrations documentation requests.
• Assist with leaflets/IFU labeling maintenance.
• Collaborate on regulatory changes affecting products.

Skills

Regulatory affairs

English language

Italian language

Regulatory knowledge

Education

Technical degree

Job description

Orthofix in Bussolengo (Verona) seeks a Junior Regulatory Product Maintenance specialist to join Regulatory Affairs on a 1-year temporary contract. You'll collaborate across departments to keep Product Technical documentation compliant and up to date, supporting international registrations and labeling updates.

The role requires a technical degree, 1 year in a related medical device setting, and strong English/Italian language skills. Travel ~10% expected.