The Manager Regulatory Affairs is responsible for regulatory leadership in project teams by providing regulatory guidance throughout the full product development cycle of medical devices, diagnostics, and combination products. Manages a team within the department or cross-functionally to provide innovative solutions and strategic regulatory support and guidance for product development from preclinical through registration and post-market. When serving as a Project Lead, the Manager Regulatory Affairs collaborates with other functions to assure the work of the entire team is delivered on time and that it meets client’s and CRG’s quality expectations. This includes creating and executing regulatory strategies, and preparation of regulatory submissions required to market new or modified medical devices, IVDs, combination products in the US and EU, along with supporting all other geographical regions registrations. Also includes support for related regulatory affairs activities, such as development and execution of procedures and systems designed to ensure that the regulatory and product development process, including clinical and performance evaluation studies, and non-clinical and analytical, addresses all regulatory requirements as well as the objectives of the business. May have direct supervisor responsibilities in addition to project team personnel; provides direction to assistant personnel.