Description
DEKA Research & Development Corp. is hiring a Regulatory Affairs Project Manager in Manchester, New Hampshire to support a medical device R&D environment. The role focuses on defining and executing regulatory strategies to achieve FDA approval/clearance and international approvals such as CE Marking, leading submissions including 510(k)s, PMAs, IDEs, and Technical Files, guiding R&D and cross-functional teams, and participating in clinical trial and FDA interaction activities. The position requires a technical bachelor's degree, at least 5 years of regulatory experience in medical device, drug, or biologic settings, strong FDA and quality-regulation knowledge, and excellent communication skills. The job is on-site, full-time, mid-level, and no remote or hybrid arrangement is offered.
