Regulatory Affairs Project Manager

Main Objective: Generates and manages submission documents for new products or changes to existing FDA filings. Maintains understanding and compliance requirements of regulatory affairs affecting company operations and products.Essential Duties and Responsibilities:1. Writes, submits, and coordinates new product 510 (k) notifications, CE Mark Technical Files/Dossiers, Canadian Submissions, Investigational Device Exemptions (IDEs) and Premarket Approval Applications. 2. Manages junior level associates/specialists by coordinating activities listed in number (1) above, and prioritizing projects and resources based on skill level of employees. Teaches junior level employees the aspects of Regulatory Affairs through on-the-job training, courses, seminars, etc.3. Determines governmental regulations affecting the following processes and assures they are complete and accurate to insure company compliance.• Maintains FDA registration and listing files - including interim and annual reports.• May participate in Quality System Audits conducted by FDA and CE Notified Body.• Assist Legal Department in compliance and litigation issues.• Assist Quality Assurance Department in maintaining the Quality System compliance program.• International regulatory compliance, submissions, and approval liaison.• Advises appropriate personnel of regulatory developments that affect their operations, products, and the corporation.• Corporate liaison between all regulatory city, county, state, and federal agencies concerning medical devices such as Florida DHRS and FDA.4. Participates in product safety alert/recall policy development and coordinates recalls.5. Reviews and monitors clinical and animal studies. Submits interim and annual clinical data to FDA.6. Reviews and approves Investigational Device shipping orders to assure that the institution and investigator are approved prior to shipment of the product.7. Periodic additional FDA course training to keep abreast of regulatory developments.Requirements: Education and Experience:4-year degree in Science or Engineering. Training in technical aspects of regulatory affairs. 7+ years direct experience in Regulatory Affairs.Knowledge and Skill Requirements/Specialized Courses and/or Training:High degree of understanding of regulatory requirements - how they operate, how to obtain updated information and where to obtain interpretations of them. RAC Certification a plusMachine, Tools, and/or Equipment Skills:PC, Databases

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