Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers). The CRE Program Manager writes and manages risk evaluation files, performs risk analysis, manages the development of clinical evaluation plans and reports and interacts with various cross-functional teams in order to assist in strategy, plans, and project deliverables.