Diagnostics Regulatory Project Manager

About the role

Roche is seeking a Diagnostics Regulatory Project Manager to lead the preparation and maintenance of regulatory documentation for In Vitro Diagnostics (IVD) and medical devices. The role ensures domestic and international regulatory approvals are achieved and sustained, with a strong focus on FDA requirements.

Key responsibilities

• Provide regulatory support for marketed products, including labeling, product and manufacturing changes, and documentation required for agency approvals.
• Create, maintain, and obtain approval for regulatory submissions and ongoing compliance documents such as stability reports, manufacturer workflows, and compositions.
• Prepare change assessments, collect data from internal stakeholders, and generate reports for regulatory affairs project teams.
• Maintain the Regulatory Information Management System (RIMS), including product information, technical files, and reporting.
• Support the development of educational materials and contribute to regulatory process improvement initiatives.

Required profile

• Bachelor's or Master's degree with ideally 5 years of experience in regulatory affairs, R&D, quality, operations, or clinical functions.
• Demonstrated FDA regulatory experience and ability to manage moderate‑to‑global projects autonomously.
• Fluent English communication skills and proven capability to influence across business areas.
• Technical knowledge of supported products and a commitment to continuous learning throughout the product lifecycle.

Required skills

• FDA regulatory experience
• Regulatory documentation preparation
• Regulatory Information Management System (RIMS) usage