Senior Global Regulatory Strategist - Medical Devices

Orthofix; Rovigo; In loco; EUR 43.000 - 45.000; Tempo pieno

Vantaggi offerti da questo lavoro

Smart working

Canteen

Health Insurance

Pension Fund

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Descrizione del lavoro

Orthofix in Bussolengo (VR) seeks a Senior International Regulatory Specialist to drive global product registrations and maintain up-to-date regulatory File Documentation. You will collaborate with Quality Engineering, R&D and Sales to ensure timely submissions, support regulatory strategies for new and modified products, and manage submissions across international markets including FDA and MDR programs.

Join a dynamic, international team with smart-working options, competitive rewards, and

Competenze

• Technical degree in a related field with 5+ years in regulatory or medical device industries.
• Excellent written and spoken English.
• Deep knowledge of international standards and regulations (FDA CFRs, European MDR, etc.).
• Strong project management skills and experience with PLM systems (Oracle).
• Good management and relationship-building abilities.

Mansioni

• Plan, prepare and maintain international product/submission registrations and licenses.
• Collaborate with Quality Engineering, R&D and other departments to assemble regulatory documentation.
• Provide regulatory intelligence and update RAMS platform.
• Support regulatory strategy for new/modified products in planned markets.
• Assist during inspections by authorities and audits.
• Manage changes in Oracle system.
• Prepare and maintain EU Technical Files and FDA Product Applications Files.
• Represent regulatory affairs in cross-functional meetings during product development.
• Handle deficiencies/nonconformities related to regulatory files.
• Manage country codes and regulatory metadata.

Conoscenze

Regulatory affairs

Project management

English proficiency

Cross-functional collaboration

Formazione

Technical degree

Strumenti

Oracle PLM

Descrizione del lavoro

Orthofix in Bussolengo (VR) seeks a Senior International Regulatory Specialist to drive global product registrations and maintain up-to-date regulatory File Documentation. You will collaborate with Quality Engineering, R&D and Sales to ensure timely submissions, support regulatory strategies for new and modified products, and manage submissions across international markets including FDA and MDR programs.

Join a dynamic, international team with smart-working options, competitive rewards, and