Government, Regulatory and Code, Quality Engineering
This position is responsible for the preparation of regulatory submissions required to market new or modified medical devices in international market. Requires the analysis of data, problem solving analysis and in depth evaluations of various factors.
• Compile labeling, brochures/catalogs, technical information for product registration.
• Coordinate and collect specific registration information with R&D, Manufacturing, QA, Sales.
• Request CFG (certificate to foreign government) from the FDA
• Obtain legalize documents from County, State, Federal and consulate/embassy
• Support International Registrations as it relates to product changes and/or new product launches
• Ability to work with minimal supervision.
• 3 years Regulatory Affairs experience in medical device companies
• International product registration experience preferred.
• Proficient in using Microsoft Word, Excel and PowerPoint.
• Strong communication and project management skills.
• Must be able to handle multiple tasks and attention to detail.