Diagnostics Regulatory Project Manager
Roche · San José
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
The Opportunity:
As a Diagnostics Regulatory Project Manager you will be responsible to oversee and complete Regulatory documentations associated with regulatory approvals of In Vitro Diagnostics (IVD) medicaid devices and Medical Devices. You are responsible for the activities that lead to and maintain domestic and international regulatory approval for marketed devices. FDA experience is required.
Responsibilities:
- 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
- Creating, maintenance and approval of regulatory documentation for submissions and for ongoing activities related to compliance with FDA and Global Regulatory directives and regulations. (e.g stability reports, manufacturer workflows, compositions, etc…)
- Prepare change assessments and general surveys when required, collect answers, create specific reports to the Regulatory Affairs project teams
- Interfaces with internal stakeholders to collect data to prepare, maintain regulatory 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 on the preparation of educational materials/presentations
- Support on Regulatory process improvement activities
Who You Are:
- Bachelor's/Master's degree
- Ideally 5 years experience, in Regulatory, R&D, Quality, Operations and/or Clinical Some experience in Healthcare regulatory affairs. FDA experience is required for this role.
- Can manage moderately work and/or global projects, or equivalent experience.
- Fluent in English language
- Proven ability to work autonomously and influence across business areas/franchises/functions
- Detailed technical knowledge of products supported and aptitude for continuing education of product changes throughout the life cycle.
Relocation benefits are not available for this job posting.
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.
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