Regulatory Affairs Manager - IVD Instruments and Software

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

A healthier future. That’s what drives us at Roche. We advance science so more people can access the healthcare they need—today and for generations to come. We work toward a world where everyone has more time with the people they love. That purpose is what makes us Roche.

At Roche Global Regulatory Affairs, we help bring the world’s leading diagnostics to the people who need them. We’re looking for a colleague who wants to make a meaningful contribution to that mission.

In this role, you’ll support regulatory projects and strategic topics across Laboratory Instruments, consumables and Software, including integrated hardware and software instrument systems. Your focus will be our Pathology and Digital Pathology portfolio within the Pathology Customer Area. You’ll work in an open, collaborative environment, partnering with colleagues across functions and countries to help shape regulatory pathways and support patient access to innovative diagnostics.

The Opportunity

• You oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of more complex products/programs. You develop and manage parts of comprehensive global regulatory submissions and registration plans. Specifically, you bring knowledge of USFDA regulations including IVD Instrument and Software, Accessories and System Reagents
• You interface with external management. You understand the structure, key roles and responsibilities of external customers/stakeholders and communicate timely and effectively the needs of external customers/stakeholders. You build effective and enduring external relationships and apply effective stakeholder management practices. You contribute to audits by supporting preparation, execution and follow up.
• You lead the organization to adapt to the evolving regulatory environment and requirements. You have an understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making. You have the ability to interpret and apply understanding of the regulators' thinking to projects and apply strategies to the different needs of different regions without significant guidance. You proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate world wide approvals.