The Program Manager will provide regulatory and quality support for product submissions, approvals, and launch readiness. You will work hand in hand with multi-functional teams and may provide individual contribution to meet the team’s objectives. You will be responsible for developing program timelines, tracking submission and quality system deliverables, and providing support for regulatory submissions, by coordinating with various internal and external team members. You will collaborate closely with multiple teams to drive global product launch readiness. In addition, you will drive day-to day program activities, generate and own reports and dashboards, and conduct risk assessments to meet overall program objectives.Responsibilities include:• Establish and handle Quality Design History File documentation timelines and successful execution across multiple cross-functional partners • Lead all aspects of regulatory submissions and approvals for portfolios of work• Establish a robust understanding of the overall critical path to coordinate activities and resolve problems alongside cross-functional partners• Communicate program status and raise risks to a variety of team members• Collaborate with external partners, vendors and consultantsThis is a site based role.