Job description
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.
