Norman, Oklahoma, 73069
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.
STEMHUNTER is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, and gender expression), national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law. We comply with all applicable equal employment opportunity and affirmative action regulations.
