Regulatory Affairs Specialist

Responsible for regulatory submissions for in vitro diagnostics and medical devices (including instruments, reagents, and software), and for developing market entry strategies in collaboration with related departments. Lead the acquisition and maintenance of marketing approval through PMDA consultations and negotiations with regulatory authorities (MHLW and PMDA).

Handle internal regulatory affairs operations, including change control and review of materials and documentation. Responsible for training and supervising staff.

Requirements

Minimum of 3 years’ experience in regulatory submissions for in vitro diagnostics and medical devices (experience with Software as a Medical Device [SaMD] is strongly preferred), with a proven track record of proactively expanding scope of responsibilities and delivering results. Basic knowledge of regulatory laws and regulations, along with an academic background in life sciences (e.

g., biochemistry, immunology, genetics) and the ability to interpret data. Proficiency in reading and writing in English is required (spoken English is a plus), as well as strong logical thinking and excellent documentation skills. Leadership to independently drive projects, strong coordination and communication skills with both internal and external stakeholders, and a proactive, growth-oriented mindset with flexibility and willingness to take on new challenges.