RA Admin II

The Admin I Regulatory Affairs assists the Regulatory Specialists to compile and submit necessary information for domestic and international registration of products marketed by CONMED. Assists with other regulatory documentation as required by FDA and individual countries. Key Duties and Responsibilities Assemble information required for domestic and international submissions. Be familiar with product registration requirements in international markets. Assist the Specialists in assembly and update of Technical Files and Dossiers. Initiate Regulatory Strategy forms and Notes to File as required for new and modified products. Maintain Regulatory database. Compile information for Medical Device Listings and Certificates to Foreign Government. Research and compile information required for customs and sales force requests. In addition to the main responsibilities listed above the manager is allowed to USE discretion TO add further duties and tasks based on the business needs which are not explicitly listed here. Job Requirements Minimum Requirements Education: N/A Experience: Minimum 1-3 years of related experience. Other Attributes: N/A Physical Requirements - Ability to sit/stand for 8 hours Preferred Requirements Education: N/A Experience: N/A Other Attributes: Clinical research and writing experience preferred Physical Requirements: N/A ADA Disclosure The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. #J-18808-Ljbffr