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 global 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 / Incentivos 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 (San Cugat del Vallés)
🏢 Roche
📍 San Cugat del Vallés