Project Manager

Project Manager | Fremont, California, United States Project Manager - IVDR Technical Files & Label Cutover Location: Fremont, CA (Contract) Division: Clinical Diagnostics - Niche Diagnostics About the Role Join a pioneering leader in the diagnostics industry as a Project Manager driving critical IVDR Technical File assembly and Label Cutover initiatives. You will play a central role in ensuring regulatory compliance and the successful transition of product labeling across a diverse diagnostics portfolio. Collaborate with top-tier teams in Regulatory Affairs, Quality, R&D, Supply Chain, and Commercial Operations, contributing to impactful projects that shape the future of clinical diagnostics. Responsibilities - Lead end-to-end management of IVDR Technical File and labeling projects, from initiation through implementation - Develop, track, and update comprehensive project plans, timelines, risk registers, and status reports - Coordinate cross-functional teams to achieve deliverables on schedule and escalate issues as needed - Facilitate project meetings and ensure timely execution of action items - Support change management for product labeling and regulatory submissions - Collaborate across Regulatory, Quality, Operations, Supply Chain, Manufacturing, and Marketing to align project goals - Maintain accurate project documentation in accordance with quality and regulatory standards - Track readiness, inventory, and cutover milestones for successful product transition - Identify and mitigate risks impacting regulatory timelines or market continuity Required Skills and Experience - Bachelor's degree in Life Sciences, Engineering, Business, Regulatory Affairs, or related field - 3-5 years' experience in project management, coordination, regulatory, quality, or operations within a regulated industry (medical device, diagnostics, healthcare) - Proven track record managing cross-functional projects with multiple stakeholders - Strong organizational and communication skills with attention to detail - Proficiency in Smartsheet, Excel, PowerPoint, and collaboration tools - Ability to manage multiple priorities in a dynamic environment - Effective facilitator with a proactive, collaborative mindset Preferred Skills - Exposure to IVDR or regulated product environments - Experience with regulatory compliance, labeling changes, or technical documentation projects - Knowledge of medical device or diagnostic regulatory requirements Benefits - Opportunity to make a significant impact in a globally recognized diagnostics division - Professional growth through collaboration with industry leaders and exposure to cutting-edge regulatory projects - Supportive, innovative, and cross-functional team environment - Flexible contract role with potential for extension How to Apply Ready to advance your career in diagnostics project management? Submit your application and join a team dedicated to excellence, innovation, and compliance.