Program Manager

As a Program Manager, you will lead a critical cross-functional initiative to ensure the regulatory readiness of technical documentation for in-market clinical diagnostic products. You will partner with various departments to support global product registrations and drive the execution of remediation plans for documentation gaps. This role requires strong program management skills and the ability to bring structure and accountability to complex projects within a regulated environment.

• Lead cross-functional regulatory compliance program for clinical diagnostic products
• Develop and maintain integrated program plans, timelines, and resource requirements
• Coordinate activities across Regulatory Affairs, R&D, Quality, Marketing, and Operations
• Assess technical documentation for regulatory submission readiness
• Identify and drive remediation plans for documentation and compliance gaps
• Manage program risks and facilitate governance reviews