Med Tech Regulatory Product Specialist (Technical Files)

Orthofix; Bussolengo; In loco; EUR 55.000 - 75.000; Tempo pieno

Vantaggi offerti da questo lavoro

Canteen

Training and development opportunities

Competitive reward packages

Social and company events

Descrizione del lavoro

Orthofix in Bussolengo (Verona) seeks a Technical Product RA Specialist to join Regulatory Affairs, supporting regulatory documentation for EU/US markets and coordinating with Quality Engineering and R&D. The role is a maternity substitution and reports to Regulatory Affairs Manager.

Responsibilities include maintaining EU and FDA documentation, ensuring regulatory conformity, and contributing to product registrations across markets. Travel up to 10% is expected.

Competenze

• 3+ years in similar position preferably in a Medical Device Company.
• Good English, both written and oral.
• Deep knowledge of international standards and regulations (in particular US-FDA/CFRs European MDR, etc).
• Technical knowledge of the Company’ Products and of the manufacturing processes.
• Project management. PLM system Oracle system

Mansioni

• Prepare and maintain up-to-date Regulatory Product Documentation Files (EU MDR, FDA 510(k)) for new or modified products.
• Collaborate with Quality Engineering and R&D to ensure regulatory compliance.
• Edit and amend the Technical File structure and verify regulatory conformity for EU, US and ROW submissions.
• As a member of the Technical Review Board, coordinate with departments to translate product inputs into regulatory requirements.
• Assess and address regulatory requirements for new or modified products and design changes before market release.
• Prepare and maintain Updated EU Product Technical Files and FDA Product Applications Files in collaboration with departments.
• Represent Regulatory Affairs in project design phases and cross-functional meetings with a regulatory perspective.
• Manage Deficiency/Non-conformity related to RA Product Technical Files with other departments.
• Maintain updated Procedure Pack Files and country code management in Oracle.
• Manage changes by ECO in Oracle system.
• Travel 10%.

Conoscenze

Regulatory affairs

English proficiency

Project management

PLM Oracle

Regulatory submissions

Strumenti

Oracle PLM

Descrizione del lavoro

Orthofix in Bussolengo (Verona) seeks a Technical Product RA Specialist to join Regulatory Affairs, supporting regulatory documentation for EU/US markets and coordinating with Quality Engineering and R&D. The role is a maternity substitution and reports to Regulatory Affairs Manager.

Responsibilities include maintaining EU and FDA documentation, ensuring regulatory conformity, and contributing to product registrations across markets. Travel up to 10% is expected.