Project Manager

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.