The role of the Regulatory Affairs Specialist involves the preparation and upkeep of regulatory submissions for in vitro diagnostic products in accordance with U.S. FDA regulations. This position is also tasked with ensuring continuous compliance through the management of registrations, labeling practices, and post-market reporting obligations. Applicants should have a bachelor’s degree in a relevant field and a minimum of 2 years of experience in an environment governed by U.S. FDA regulations. A solid understanding of medical device regulations, ISO 13485 standards, and strong technical communication abilities are essential for this role.
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.
