Regulatory Affairs Associate

To support regulatory compliance efforts, the full-time Regulatory Affairs Associate will prepare IVD regulatory documents for submission to various domestic and international regulatory agencies while working remotely within the U.S. Key responsibilities Prepare documentation for regulatory submissions and interact with regulatory bodies to complete product registrations Maintain knowledge of submission requirements and assess compliance of labeling, promotional, legal, and technical documentation Standardize regulatory operations and establish clear protocols based on current regulations impacting products and processes Required qualifications Bachelor's degree in a related discipline or equivalent education/job experience; 2+ years of Regulatory Affairs experience required for Specialist level Familiarity with FDA, IVDD, IVDR, ISO 13485, GMP, and other major international regulatory requirements Experience in a regulated environment, preferably in Medical Devices or IVDs Proven ability to work independently and as part of a team in a fast-paced environment Effective technical writing skills and ability to organize information for clarity and ease of review