Regulatory Affairs Specialist
Posted Updated
Description
- 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.