Job Summary: Determine current regulatory requirements and strategies for Terumo Medical Corporation and Terumo Corporation projects. Defines information and actions necessary to meet these requirements. Prepares documents and or submissions required to obtain clearance or approval from government agencies for commercial distribution of products worldwide. Serves as a liaison between the FDA and Terumo Medical Corporation. Mistakes made in this area can be very costly, i.e., delays in product clearance or approval withdrawal of product from the market place, or enforcement of fines. Any of the above would have a major impact on the corporation. Job Details: 1. Associate is responsible to follow requirements of applicable national and international regulations. 2. Analyze data received and prepare documentation for submission for the purpose of obtaining clearance and or approval for product distribution. 3. Participates on product design teams and verifies compliance with design control requirements and procedures. 4. Determine appropriate regulatory requirements and strategies for TMC, TPC, TMPH, and TC projects including both domestic and foreign activities and provide regulatory consultation to other internal and external entities. 5. Acquire and maintain a current knowledge of federal regulations pertaining to the lawful distribution of products which include facility registration, device listing, labeling and promotional review. 6. Maintain documentation and a historical record for projects and provide management with updated product status. 7. Participate in task force groups. 8. Maintains current knowledge of Federal USA and Canadian regulations pertaining to legal distribution of medical products. Stays abreast of FDA updates including new policies and guidances. 9. Demonstrates the ability to interact with production division, federal agencies, industry organizations, interdepartmentally and external departments at all levels. 10. Assists external customers by supplying materials and documentation for US and foreign product registrations as well as certification of appropriate US commercialization status. 11. Must make a proactive contribution to the overall Regulatory affairs department growth. 12. Must be able to provide general regulatory consultation during absence of other associates and/or manager. 13. Participates in project performance team meetings on behalf of the business unit in order to provide ideas, methods or processes for unit/company performance improvement. 14. Performs other job related duties as assigned.
Position Requirements: Knowledge, Skills, and Abilities o Requires ability to complete internal update preparations independently and completion of at least five (5) during TMC employment (or equivalent at prior employment). o Advanced ability for independent work, team work, and decision making o Making correct decisions based on interpretations of federal laws, which in many instances are very general in nature to accommodate a variety of industries. These interpretations are used for every aspect of the regulatory discipline from submissions to labeling issues. o Regulatory Affairs Certification preferred. Background Experience o Typically requires a 4 year degree in life sciences. o Minimum 5 years experience in Regulatory Affairs. o Must have completed three (3) 510(k) submissions and demonstrated ability to prepare submissions independently.