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Job #02995

About our client Our client is a medical device company located in Naples, Florida. They focus on providing the finest quality engineered products and educational services for orthopedic surgeons. With over 3,000 products for arthroscopic and orthopedic surgical procedures (shoulder, knee/hip and small joint), our client has built up a strong customer base across the USA and in 60 countries worldwide. This is a great opportunity for the right candidate! Position Location Regulatory Affairs Manager Naples, Florida Salary Highly competitive package, commensurate with experience Responsibilities 1) Generate and manage submission documents for new products or changes to existing FDA filings 2) Maintain an understanding of compliance requirements of regulatory affairs affecting company operations and products 3) Write, submit and coordinate new product 510(k) notifications, CE Mark technical files/dossiers, Canadian submissions, Investigational Device Exemptions (IDEs) and Premarket Approval Applications 4) Manage junior level associates/specialists by coordinating activities as well as prioritizing projects and resources based on skill level of employees 5) Coach junior level employees on the aspects of regulatory affairs through on-the-job training, courses, seminars, etc. 6) Determine governmental regulations affecting processes and ensure that they are complete and accurate 7) Maintain FDA registration and listing files, including interim and annual reports 8) Assist Legal Department in compliance and litigation issues 9) Participate in quality system audits conducted by FDA and CE notified bodies 10) Assist Quality Assurance Department in maintaining the quality system compliance program, international regulatory compliance, submissions and approval liaison 11) Advise appropriate personnel of regulatory developments that affect their operations, products and the company 12) Ensure corporate liaison between all regulatory city, county, state and federal agencies concerning medical devices (such as Florida DHRS and FDA) 13) Participate in product safety alert/recall policy development and coordinate recalls 14) Review and monitor clinical as well as animal studies 15) Submit interim and annual clinical data to the FDA 16) Review and approve investigational device shipping orders to ensure that the institution and Investigator are approved prior to shipment of the product 17) Participate in periodic additional FDA course training to keep abreast of regulatory developments Requirements 1) Degree (4 year) in Science or Engineering 2) 7+ years of experience in regulatory affairs 3) RAC certification a plus 4) Trained on the technical aspects of regulatory affairs 5) In-depth understanding of regulatory requirements 6) Proficient in computers with the ability to work on databases