Medical Device Regulatory Affairs Specialist

This role handles regulatory applications and certification procedures for medical devices intended for domestic and international markets. Responsibilities include planning regulatory submission schedules based on business plans, managing progress, preparing and submitting application documents, providing required information to third-party certification bodies and overseas subsidiaries, and responding to inquiries from authorities after submission.

The role covers communication with Japan’s Ministry of Health, Labour and Welfare and PMDA, the US FDA, China’s NMPA, and other overseas regulatory authorities. In the component business, including digital radiography and ophthalmic products, the position works with design, quality, and business departments from the early development stage. Duties include organizing requirements based on regulations in each country, developing technical documentation, negotiating with regulatory authorities and certification bodies, and managing post-market changes across the product lifecycle.

Applicants should actively communicate, approach challenges positively, take initiative, and make effective use of support from colleagues and related departments. Required knowledge and experience include work experience involving basic physics and electrical knowledge at a manufacturing company, along with the ability to read and write simple English. Experience with medical-device regulatory submissions and certification, basic knowledge of ISO 13485 or IEC 60601, and basic clinical knowledge are welcome.

The position is initially supported through on-the-job training covering products, regulations, and internal processes. Responsibility for countries and products expands according to experience. Work is conducted in a small team of approximately three people, with the possibility of progressing to lead responsibility and regulatory strategy duties.

The employment type is permanent employment. The work locations are Canon’s Shimomaruko headquarters in Ota, Tokyo; the Kosugi site in Nakahara, Kawasaki, Kanagawa; and the Nasu site in Otawara, Tochigi. Working hours are 8:30–17:00. The position includes a five-day workweek in principle on Saturdays and Sundays, public holidays, year-end and New Year holidays, a May holiday period, and summer vacation, with 125 annual holidays. Benefits include transportation and overtime allowances, social insurance, retirement benefits, a corporate pension, savings and employee stock ownership programs, training, childcare-related shorter working hours, recreation facilities, and internal events. Annual salary is JPY 4.3–8.7 million; overtime pay is provided separately except where the employee is hired as a managerial supervisor, and the final treatment is determined based on experience and ability.