Regulatory Specialist Diagnostics

at  Roche

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
As a Regulatory Specialist you will be responsible to compile documents and deliverables to support planned product registration timelines. You will maintain product registration throughout a product’s lifecycle by applying successful regulatory change control. You will maintain clear agreement with other functions, stakeholders, and external partners (such as health authorities, companies, and notified bodies) to promote success of the registration activities and strategies. Collaborates with other functions in the organization to obtain regulatory approvals for products with defined markets.

• Provides support to currently marketed products, e.g., labeling, product and manufacturing changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to regulatory requirements. This includes annual reporting and laser reporting in relevant countries.
• Interfaces with internal stakeholders to collect data to prepare, maintain regulatory documentation. This includes internal documentation decisions and review of analytical data report review and authoring of relevant analytical documentation.
• Maintain documentation of the Regulatory Information Management System
• Create and maintain product information on the Regulatory Information Management System
• Create reports on Regulatory Information Management System
• Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations
• Support for documentation management system workflows
• Support for any appropriate submission activity, including PMA supplements, 30-day notices and certain 510(k)
• SRD and IDE memos
• Support international regulatory submissions by provision of needed data and documents; answering Health Authority questions on the submissions; keeping our Affiliates informed about new products /projects/ process changes etc