Company Culture

At 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 Overview The 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 Responsibilities

Leading and supporting regulatory strategies for global IVD/MD instruments and software submissions





Ensuring compliance with international regulatory requirements and standards

Collaborating with cross-functional teams, including R&D;, Quality, and Clinical, to drive regulatory initiatives

Providing regulatory guidance to support product development and lifecycle management

Staying abreast of evolving regulatory trends and updates, and implementing best practices

Requirements

Bachelor’s Degree in Life Sciences, Regulatory Affairs, or a related field

5 to 7 years of experience in Regulatory Affairs (Regulatory, R&D;, Quality and/or Clinical), with some experience in healthcare regulatory affairs

In-depth knowledge of global regulatory requirements, guidelines, and procedures especially for IVD instruments & software

Strong organizational and communication skills

Ability to multitask and effectively manage multiple projects simultaneously

Self‑motivated and capable of working independently in a self‑management environment

Experience in IVD instrument and/or software development

Benefits

Collaborative and innovative work environment

Opportunity to make a meaningful impact on patients' lives globally

Competitive compensation and benefits package

Professional development and growth opportunities within a leading global healthcare organization

Roche is an Equal Opportunity Employer.

📌 Regulatory Affairs Manager (Madrid)
🏢 F. Hoffmann-La Roche
📍 Madrid