Regulatory Affairs Associate

Main Job Responsibilities/CompetenciesAssist RA Director with FDA and international regulatory submissions including 510(k), PMA, technical dossiers and registrations, as needed for Class I, II and III medical devices under.Preparation of Standard Operating Procedures (SOPs) for the department.Compile necessary periodic reports for the FDA.Work with R&D, Clinical and Marketing and provide support when needed.Review proposed labeling to ensure that the intended use and claims are supported for use and domestic and international regulations are met.Participate in compliance activities that relate to the department and the company as a whole.

Education & TrainingBachelor of Science degree in a scientific related field


ExperienceMinimum 1 to 5 years related experience, or equivalent combination of education and experience required


SkillsThorough understanding of FDA and international regulations
Strong working knowledge of medical devices regulations and terminologiesExcellent written and oral communication, and technical writing and editing skillsAbility to write clear, understandable technical documentationSkilled at analyzing and summarizing dataProficient with Microsoft OfficeAbility to manage and prioritize multiple projectsAbility to follow written and verbal directions with a  high level of accuracyAbility to work independently with minimal supervisionExtreme attention to detailAbility to work in a team setting