Director Of Regulatory Affairs Jobs in New Hampshire

Job Title: Project Regulatory Affairs Manager Company: Location: Manchester, NH Description: We have an immediate opening for a Project Regulatory Affairs Manager to work in a dynamic Medical Device Research and Development environment. This is a high visibility role with a significant direct impact on the success of the various innovative projects that DEKA is currently developing. Responsibilities will include taking the regulatory lead in planning and obtaining regulatory approvals in the US and obtaining the CE mark on international applications. Activities will include defining regulatory strategies, implementing regulatory plans, preparing and submitting regulatory applications which may include 510(k)?s PMA?s IDE?s, etc. The selected individual will participate and possibly lead in Agency regulatory meetings, teleconferences, and other Agency communications as needed. As the lead regulatory person on assigned projects this individual will be the primary regulatory contact person to interface with our customers on matters of a regulatory nature. The Project Regulatory Manager will also participate in the design and conduct of clinical trials and assist in obtaining the appropriate regulatory approvals from the FDA, IRB?s and/or Ethics Boards. Candidates must have had a minimum of 5 years direct work experience in a regulatory role and demonstrated success in obtaining regulatory approvals. Candidates must have a minimum of a BS degree. Experience in Medical devices, knowledge of FDA?s Quality System Regulations (QSR?s), and other medical device industry experience is desired. Please send resumes with subject line "Regulatory Manager" to Register to View