Project Manager

About the role

The Project Manager will lead complex cross-functional initiatives within an FDA-regulated medical device, pharmaceutical, biotechnology, or diagnostics environment. Candidates must have at least 5 years of project and/or program management experience supporting regulated product development, manufacturing, quality, validation, regulatory, or commercialization activities. The ideal candidate has hands-on experience navigating Design Controls, Quality Systems, GMP requirements, Validation processes, and other regulatory requirements that govern product development and commercialization. This role is responsible for driving project execution from concept through launch, coordinating cross-functional teams, managing project plans, schedules, budgets, risks, and deliverables, and ensuring alignment with business objectives and regulatory expectations. Strong proficiency with project management tools is required, with Smartsheet experience highly preferred. Candidates who have leveraged Smartsheet to build project plans, manage timelines, monitor dependencies, and provide project visibility across stakeholders will be particularly