Universities launch joint training for medical device regulatory affairs specialists

Sangji University's Anchor Project Group, in collaboration with Kangwon National University's Anchor Project Group, has launched an intensive training program focused on Regulatory Affairs (RA) for medical devices. The program commenced with an opening ceremony at Kangwon National University's Dogye Campus on June 22 and is scheduled to run until June 27.

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This training program is the starting point for cultivating practical talent that connects inter-university cooperation with the demands of regional strategic industries.

This initiative is particularly significant as Sangji University was officially designated as an RA expert training institution by the Korea Medical Device Safety Information Service in April. This recognition underscores the university's capabilities in nurturing professionals for the bio-health and medical device sectors. The program provides students with a structured pathway to gain the necessary qualifications for the RA expert certification exam, thereby enhancing their prospects in the industry.

Regulatory Affairs in the medical device field encompasses the entire product lifecycle, from design and development to clinical trials, approval, quality management (GMP), and post-market surveillance. The demand for skilled RA professionals is rapidly increasing, driven by the growth of the digital healthcare industry and evolving global regulations. This training program aims to equip students with the practical, on-the-ground skills required in this dynamic field.

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Regulatory science for medical devices is a core field that ensures product safety and efficacy and enhances industrial competitiveness. We expect trainees to build expertise through this intensive training and grow into talents who contribute to the development of the bio-health and medical device industry in the Gangwon region.

The intensive 40-hour curriculum covers essential knowledge for the medical device industry, including product development, domestic and international certifications, and quality control. Upon completion, participants will be eligible to take the Level 2 national certification exam for RA specialists, laying a solid foundation for careers in medical device approval and the broader bio-health sector.

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With Sangji University's official designation as a medical device RA expert training institution, students now have a foundation to link university-led training courses with eligibility for the certification exam.

The program has attracted a total of 46 students: 20 from Sangji University, 18 from Kangwon National University, and 8 from Gachon University. The opening ceremony included welcoming remarks from leaders of the participating universities and officials from the Health Insurance Review & Assessment Service. The event emphasized the importance of inter-university cooperation and the program's role in cultivating practical talent to meet regional industry demands. Discussions also took place regarding further collaboration on talent development and retention in the bio-health and medical device sectors within the Gangwon region.

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This program goes beyond simple theoretical education, supporting students in career exploration, preparation for certification, and strengthening their employability.