Company CultureAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. We aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.Position OverviewThe Position At Roche, we believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and we are brave in both decision and action. And we believe that good business means a better world. Join Our Team: Make a Difference in International Regulatory Affairs!Roche is seeking a dynamic and highly motivated individual to join our team as an International Regulatory Affairs Professional. We are looking for candidates who bring an innovative and creative mindset to the table, along with a proven track record in the Regulatory Affairs field. If you are passionate about making a positive impact on integral healthcare through regulatory excellence,



we invite you to be part of our dedicated team.Key ResponsibilitiesLeading and supporting regulatory strategies for global IVD/MD instruments and software submissionsEnsuring compliance with international regulatory requirements and standardsCollaborating with cross-functional teams, including R&D;, Quality, and Clinical, to drive regulatory initiativesProviding regulatory guidance to support product development and lifecycle managementStaying abreast of evolving regulatory trends and updates, and implementing best practicesRequirementsBachelor’s Degree in Life Sciences, Regulatory Affairs, or a related field5 to 7 years of experience in Regulatory Affairs (Regulatory, R&D;, Quality and/or Clinical), with some experience in healthcare regulatory affairsIn-depth knowledge of global regulatory requirements, guidelines, and procedures especially for IVD instruments & softwareStrong organizational and communication skillsAbility to multitask and effectively manage multiple projects simultaneouslySelf‑motivated and capable of working independently in a self‑management environmentExperience in IVD instrument and/or software developmentBenefitsCollaborative and innovative work environmentOpportunity to make a meaningful impact on patients' lives globallyCompetitive compensation and benefits packageProfessional development and growth opportunities within a leading global healthcare organizationRoche is an Equal Opportunity Employer.
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📌 Regulatory Affairs Manager (San Cugat del Vallés)
🏢 F. Hoffmann-La Roche
📍 San Cugat del Vallés