This position is responsible for providing product management for the Navitus Medicare Part-D program, leading efforts to design, develop, implement, and oversee various Medicare Part-D processes that align with both client expectations and ensure Navitus meets compliance requirements as defined by the Centers for Medicare and Medicaid Services (CMS).

The Start Up Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning. Will act as Subject Matter Expert for questions by other in-country members supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents.

The Regulatory Affairs Specialist will support frequent minor software releases and the EU MDR application. This role involves cross-functional collaboration for product changes, maintenance of documentation, and managing new product registrations. This individual will play a key role in HeartFlow regulatory activities for product changes.