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