Regulatory Affairs and FDA Submission Support

The contract provides comprehensive regulatory affairs support focused on ensuring full compliance with U.S. Food and Drug Administration requirements for a transcatheter aortic valve replacement device. This includes end-to-end assistance with preparing and submitting premarket notifications (510(k)) and premarket approval applications (PMA), as well as maintaining all necessary documentation to meet FDA standards during the development and commercialization phases. The contractor will be responsible for managing the regulatory strategy, coordinating technical documentation, and facilitating timely submissions to secure FDA clearance or approval. Additionally, the contract encompasses ongoing post-market regulatory responsibilities such as adverse event reporting, device labeling compliance, surveillance activities, and periodic reporting obligations to ensure continued market authorization. The work is being performed under a subcontract arrangement managed by the Department of Veterans Affairs through the Network Contract Office 23, with the North American Industry Classification System code 541611 indicating professional, scientific, and technical services related to administrative management and regulatory consulting. All activities must align with federal regulatory frameworks and be conducted in a manner that supports the safe and effective use of the TAVR device within the VA healthcare system.