Regulatory Affairs Associate

Job Summary

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