Project Regulatory Affairs Manager

Company Name:
DEKA Research & Development
Position Type:
DEKA Research & 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.
Prepare and submit regulatory applications such as 510(k)s, PMAs, IDEs, etc.
Participate in and lead FDA regulatory meetings, teleconferences, and other Agency communications as needed
Interface with our customers on matters of a regulatory nature
Participate in the design and conduct of clinical trials, and assist in obtaining the appropriate regulatory approvals from the FDA, IRBs and/or Ethics Boards
Desired Qualifications
BS in a technically related field
Minimum of 5 years direct work experience in a regulatory role and a demonstrated success in organizing and conducting FDA meetings and filing regulatory submissions
Experience in U.S. Medical Device Regulations, including Quality Systems Regulations (QSRs), ISO 13485, Establishment registration, UDI labeling, and CE Marking requirements

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