CRA Regulatory Operations Manager

Overview Regulatory Affairs Specialist Responsibilities Direct, oversee and manage large, complex regulatory projects, ensuring quality deliverables on time and within budget. Act as Project Manager for a large and complex stand‑alone project or program. Prepare and submit FDA 510(k) submissions, periodic updates, Canadian applications, and registrations. Exercise delegated managerial authority to plan, direct, and execute a program and its segments. Conduct effective and unbiased oversight supporting the product and service offerings. Ensure compliance with regulatory and industry standards across operations. Qualifications Experience in regulatory compliance and FDA submissions. Strong project management skills. Knowledge of regulatory compliance regulations and operational procedures. Ownership and execution of compliance procedures and screenings. Benefits $80.00 hourly or $135,000 yearly (dependent on role variant). Full‑time employment. Remote or hybrid options available. #J-18808-Ljbffr