Regulatory Affairs Manager

apartmentRoche placeSant Cugat del Vallès calendar_month3/7/26

Experteer Overview

Join Roche as an International Regulatory Affairs Professional to drive regulatory excellence for global IVD/MD instruments and software. You will collaborate with Ru0026amp;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 / Beneficios

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

Responsabilidades

Bachelor’s Degree in Life Sciences, Regulatory Affairs, or related field
5 to 7 years of experience in Regulatory Affairs (Regulatory, Ru0026D, Quality and/or Clinical)
Deep knowledge of global regulatory requirements, guidelines, and procedures for IVD instruments u0026 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

Requisitos principales

competitive compensation and benefits package
professional development and growth opportunities

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