Project Manager (Medical Devices III)

Job description

Job Title: Project Manager (Medical Devices III) Position Type: Contract Location: Contract Salary Range / Rate: $90/hr. to 130/hr. Job Description: We are seeking an experienced Project Manager (Consultant) to support the development, testing, and Premarket Approval (PMA) submission of a Class III long-term implantable medical device within the Implantable Device Unit (IDU). This role will provide end-to-end project leadership across design, verification and validation, manufacturing readiness, and regulatory submission activities. The Project Manager will partner closely with Device Development, Regulatory Affairs, Quality, Manufacturing, and external partners to ensure execution remains aligned with FDA expectations, design control requirements, and program timelines. Responsibilities: Project Execution & PMA Modular Submission: - Lead integrated project plans focused on finalizing design control deliverables and completing PMA Modules, ensuring alignment with regulatory milestones and submission timelines. - Drive execution of remaining verification and validation activities, ensuring traceability, documentation completeness, and readiness for regulatory review. Regulatory & Qu...