Regulatory Affairs Manager - International CDx
rocheSanta Clara (CA)
Regulatory Affairs Manager - International CDx
Posted today
rocheSanta Clara (CA)
SENIORITY
Manager
About the role
Overview:
In this role you drive regulatory approvals for IVD products globally, collaborating with cross-functional teams to keep registrations on track. You manage submissions, licenses, and Health Authority interactions, while shaping regulatory strategies and ensuring transparent communication across the organization. You’ll work within Roche’s mission to improve access to healthcare and support a world where more people benefit from innovative diagnostics. This is a hands-on, globally scoped regulatory leadership role with meaningful impact. Compensation / Benefits Discretionary annual bonus Benefits package (details via link)
Responsibilities:
Secure regulatory approvals for products within own scope by partnering with cross-functional teams Coordinate and compile submission deliverables to keep registrations on track Maintain product licenses through lifecycle and manage Health Authority notifications and change-control compliant submissions Drive regulatory strategy efficiency through strong internal and external partnerships (Health Authorities, Notified Bodies) Provide strategic regulatory input based on international requirements and support global submissions with data management and stakeholder updates Act as subject matter expert to communicate and implement complex regulatory requirements across the organization
Key requirements:
Regulatory Affairs experience in IVDs/medical devices/pharma/biopharmaceutical Knowledge of EU, US, China and other international regulations Ability to manage complex work and global project components Experience with daily management and continuous improvement practices Preferred experience in companion diagnostics Cross-functional collaboration Strategic communication Stakeholder management Regulatory submissions processes Health Authority interactions and inquiries Notified Body coordination
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