Jan 28, 2023
Job description: The Pre Market Regulatory Affairs Manager will be a working manager, responsible for determining regulatory requirements that affect the company and its products and for the process of preparing submissions to US and international regulatory agencies. The Regulatory Affairs Manager is the liaison for communication with regulatory agencies and regulatory agency inspections. This position is responsible for initiating and supporting quality systems activities in all aspects of the business, including identification and implementation of continuous process improvement activities. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: 1. Regulatory Submissions 2. Regulatory Support 3. International Regulatory Affairs 4. Regulatory Liaison 5. Labeling 6. Collaboration & Integration 7. Other duties and projects, as assigned. MANAGEMENT/LEADERSHIP RESPONSIBILITIES: manage and provide leadership to regulatory specialists at varying levels. Manageing 2...
Job Juncture
Clearwater, FL, USA