Regulatory Affairs Consultant

We are currently seeking a detail-oriented, experienced Regulatory Affairs Consultant to join our team on a contract basis. The opportunity is preferred to be on-site, but we are open to both on-site and remote options. This opportunity is ideal for a highly knowledgeable regulatory professional who thrives in a fast-paced, collaborative environment and can help support both ongoing operations and global market expansion efforts. Role & 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 #J-18808-Ljbffr