Regulatory Affairs Manager

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 global 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.