Regulatory Research Associate

Skills: Research and monitor FDA, EU MDR, and other global regulatory, regulatory intelligence reports, Medtech

Experience: 2-3 YearsWe at Coforge are hiring Regulatory Research Associatewith the following skillset: Research and monitor FDA, EU MDR, and other global regulatory requirements impacting wearable health and digital health technologies. Support the planning, preparation, and execution of regulatory submissions, registrations, and regulatory strategy documentation. Develop regulatory intelligence reports on emerging regulations, standards, competitors, and market trends. Coordinate responses to regulatory authority inquiries and support audit readiness activities. Review technical documentation, product materials, and labeling to ensure regulatory compliance. Maintain regulatory records, submission documentation, and compliance tracking systems. Partner with Product, Quality, Engineering, and Clinical teams throughout the product development lifecycle. Support the development of internal regulatory intelligence and knowledge management processes. Manage multiple projects simultaneously while tracking priorities, timelines, and deliverables. Bachelor's degree in engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, Public Health, or a related field.2-3 years of experience in regulatory affairs, regulatory research, medical devices, digital health, or healthcare technology. Experience supporting FDA and/or global regulatory submissions and documentation. Strong analytical, research, writing, and communication skills. Demonstrated ability to manage multiple priorities in a fast-moving environment. Experience with wearable devices, connected health, digital health, or wellness technologies. Familiarity with FDA regulations, EU MDR, ISO standards, and global regulatory frameworks. Experience reviewing technical documentation and product claims. Embraces ambiguity and isn't afraid of a little chaos. Learns quickly and adapts as priorities evolve. Has a strong "figure it out" mentality and takes ownership. Balances attention to detail with speed and execution. Works effectively across teams and functions. Is excited to help bring innovative healthcare technologies to market.