Overview

Join Roche as an International Regulatory Affairs Professional to drive regulatory excellence for global IVD/MD instruments and software. You will collaborate with R&D;, Quality, and Clinical teams to shape submissions, stay ahead of regulatory developments, and support product lifecycle management. This role offers meaningful integral impact through enabling access to healthcare and advancing medical solutions. You’ll thrive in a collaborative, innovative environment and help define the future of regulatory strategy at Roche.

Compensaciones / Beneficios

- competitive compensation and benefits package
- professional development and growth opportunities

Responsabilidades

- Lead and support regulatory strategies for global IVD/MD instrument and software submissions
- Ensure compliance with international regulatory requirements and standards
- Collaborate with cross-functional teams to drive regulatory initiatives




- Provide regulatory guidance to support product development and lifecycle management
- Stay informed on evolving regulatory trends and implement best practices

Requisitos principales

- Bachelor’s Degree in Life Sciences, Regulatory Affairs, or related field
- 5 to 7 years of experience in Regulatory Affairs (Regulatory, R&D;, Quality and/or Clinical)
- Deep knowledge of global regulatory requirements, guidelines, and procedures for IVD instruments & software
- Strong organizational and communication skills
- Ability to multitask and manage multiple projects
- Self-motivated with ability to work independently
- Experience in IVD instrument and/or software development

- collaboration
- communication
- self-motivation
- global regulatory requirements, guidelines, and procedures
- IVD instruments & software
- regulatory submissions

📌 Regulatory Affairs Manager (Barcelona)
🏢 Roche
📍 Barcelona