Summary
– We’re looking for a steady, responsible, mature professional that would support us in occasional work in the realm of post market activities in Japan.
– Position does not need to be based in Kobe, Japan, but would need to be there during inspections, which is infrequent.
Responsibilities
– Support occasional adverse event reporting to the PMDA
– Support on-site audit for the Market Authorization Holder (MAH) office in Kobe
– Work together with rest of Japan Team with regards to on-site inspections, and provision of information
Qualifications
– Minimum 3 years’ experience in medical device industry
– Minimum 3 years’ experience in technical service for active medical devices, and/or post market activities (complaint handling, reporting to regulatory authorities) to the PMDA/MHLW
– Minimum Bachelor’s Degree Holder
– Local Japanese