Med Tech Regulatory Affairs Specialist — Technical Files

Orthofix Holdings, Inc.; Bussolengo, Verona; On-site; EUR 40,000 - 43,000; Full time

Benefits offered by this job

Canteen Benefits

Pension Fund

Health Insurance

Training and development opportunities

Job summary

Orthofix Holdings, Inc. in Bussolengo (Verona) is seeking a Technical Product Regulatory Affairs Specialist to join our Regulatory Affairs team as a maternity substitution.

You will ensure availability of Technical Documentation File by maintaining EU MDR and FDA submission-ready files and coordinating with Quality Engineering and R&D. The role requires a technical degree and 3+ years in medical devices, strong English, and in-depth knowledge of US FDA CFRs and European MDR.

Qualifications

• 3+ years experience in regulatory affairs for medical devices.
• Strong knowledge of US FDA CFRs and EU MDR requirements.
• Experience with Technical Documentation File (EU MDR) and FDA submissions.

Responsibilities

• Prepare and maintain EU Product Technical Files and FDA Product Applications Files.
• Collaborate with Quality Engineering and R&D to ensure regulatory conformity.
• Participate in NPI reviews and ensure regulatory deliverables are delivered on time.
• Manage regulatory changes and EC in Oracle system.

Skills

Technical degree

Regulatory affairs knowledge

3+ years experience

English proficiency

FDA/EU MDR knowledge

Product knowledge

PLM system

Tools

Oracle PLM

Job description

Orthofix Holdings, Inc. in Bussolengo (Verona) is seeking a Technical Product Regulatory Affairs Specialist to join our Regulatory Affairs team as a maternity substitution.

You will ensure availability of Technical Documentation File by maintaining EU MDR and FDA submission-ready files and coordinating with Quality Engineering and R&D. The role requires a technical degree and 3+ years in medical devices, strong English, and in-depth knowledge of US FDA CFRs and European MDR.