Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist – Medical Devices About the Role We are seeking a Senior Regulatory Affairs Specialist to support global regulatory activities for medical devices. This role partners with cross‑functional teams to develop regulatory strategies, prepare submissions, and ensure products remain compliant throughout their lifecycle. Responsibilities Develop and execute regulatory strategies for medical devices. Prepare and support global regulatory submissions and product registrations. Provide regulatory guidance for product changes, labeling, and lifecycle management. Collaborate with Quality, Engineering, Manufacturing, and R&D teams. Maintain regulatory documentation and support audits and compliance activities. Monitor regulatory changes and recommend actions as needed. Requirements Bachelor's degree in a technical or scientific discipline. 5+ years of regulatory affairs experience in the medical device industry. Knowledge of FDA, MDR, ISO 13485, and global medical device regulations. Strong communication, organization, and problem-solving skills. RAC certification is a plus. If you're passionate about bringing compliant, high-quality medical devices to market, we'd love to hear from you. #J-18808-Ljbffr