Job Details
Job Summary
Japanese Medical Device company specializing in class 3 – 4 Medical Devices searching for an RA Manager for their new Tokyo Office in Shinagawa to lead team and release new products into Japan market.
Responsibilities
・ Lead a team of 2 – 4 Regulatory Affairs staff to complete RA application from start to finish on assigned products
・Be the first person of contact with Japanese authority and take charge of all RA-related negotiations
・Create reimbursement application
・Coordinate and collaborate with Quality Assurance and R&D
Qualifications
・Experience with Class 3 – 4 Medical Device Japan Regulatory Affairs process
・Management experience is a plus, but not required.
・Communication and negotiation experience with Japanese authorities such as the PMDA
