Regulatory Affairs Consultant

Responsibilities: Developing and executing regulatory strategies for U.S. and global market access (FDA, Health Canada, EU MDR, and other international markets)Preparing and maintaining documentation for 510(k) submissions, Technical Files, and product registrations Conducting regulatory assessments for new product development, labeling, and packaging Supporting product lifecycle changes, risk management, and post-market surveillance activities Ensuring ongoing compliance with U.S. FDA regulations, ISO 13485, and international medical device requirements Reviewing labeling, IFUs, and marketing materials for regulatory compliance Interfacing with internal teams and external partners to ensure clear, compliant communication and documentation Advising on regulatory implications of product changes and maintaining registration timelines

Skills & Experience: Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or a related field (Master’s or RAC certification a plus)5+ years of hands-on regulatory affairs experience in the medical device industry Demonstrated experience with both Class I and Class II medical devices Strong working knowledge of FDA submissions (including 510(k)) and EU MDR Technical Files Experience supporting international registrations and country-specific regulatory requirements Meticulous attention to detail, excellent organization and communication skills Ability to manage multiple projects independently while collaborating cross-functionally