DEKA Research & Development Corp. Project Regulatory Affairs Manager in Manchester, New Hampshire

DEKA Research and Development has an immediate opening for a Project Regulatory Affairs Manager to work in a dynamic, medical device research and development environment. The individual in this high visibility role will have a direct impact on the success of the innovative devices that DEKA develops. He or she will formulate and execute regulatory strategies resulting in FDA clearance in the U.S. as well as the CE Mark on international applications.Responsibilities:Actively participate on project teams as the Regulatory Affairs representativePrepare and submit regulatory applications such as 510(k)s, PMAs, IDEs, Pre-Submissions, etc.Ensure regulatory applications comply with applicable regulations and guidance documentsParticipate in and lead FDA regulatory meetings, teleconferences, and other Agency communications as neededInterface with our customers on matters of a regulatory natureReview proposed product changes for impact on regulatory status of the productParticipate in the design and conduct of clinical trials, and assist in obtaining the appropriate regulatory approvals from the FDA, IRBs and/or Ethics BoardsQualifications:BS in a technically related fieldMinimum of 5 years direct work experience in a regulatory role and a demonstrated success in organizing and conducting FDA meetings and filing regulatory submissionsExperience in U.S. Medical Device Regulations, including Quality Systems Regulations (QSRs), ISO 13485, Establishment registration, UDI labeling, and CE Marking requirements