The Regulatory Affairs Associate plays a crucial role in compiling regulatory documents for In Vitro Diagnostics (IVD) for both domestic and international submissions, as well as engaging with regulatory authorities. This position entails ensuring that products meet compliance standards, keeping technical documentation up to date, and developing standardized regulatory processes. Applicants should have a bachelor’s degree in a relevant field and a minimum of two years of experience in regulatory affairs. Proficiency in technical writing, excellent organizational skills, and knowledge of FDA regulations, IVD guidelines, and ISO 13485 standards are essential.
IMMY provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
