Regulatory Affairs Manager

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. This is how 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.

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

As an International Regulatory Affairs Professional at Roche, you will be responsible for:

• 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 up‐ dates, 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

Why Roche

• 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

If you are a dedicated professional who thrives in a fast-paced environment and is passionate about contributing to the
International Regulatory Affairs landscape, we want to hear from you! Submit your resume and cover letter detailing your
relevant experience and qualifications.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.