raqa manager.

YOUR RESPONSIBILITIESAct as the Management Representative for XXX during external audits.Serve as the RAQA business partner for internal stakeholders and ensure XXX processes comply with Japanese regulatory requirements.Ensure compliance of XXX products and processes with the Quality Assurance Agreement between XXX and legal manufacturers.Develop RA strategies for new products to ensure timely regulatory approvals in Japan and communicate regulatory requirements to stakeholders.Establish relationships with government agencies and internal stakeholders at XXX; train XXX associates on Japanese regulatory requirements.Apply CAPA and other continuous improvement tools, and keep abreast of Lean Management and Continuous Improvement tools like 5S, DMP, SW, and TPI to ensure high standards of process and product quality.Adhere to company EHS requirements and risk assessments; meet the requirements to be SOKATSU, with extensive experience in regulatory affairs, quality assurance, and MHLW regulations, along with strong teamwork, interpersonal communication, analysis, judgment, negotiation, and conflict resolution skills.

求められる経験
Education: Minimum bachelor’s degree in engineering or Life Sciences. Advanced degree for medical test, laboratory medicine, medical engineering, chemistry, biology and pharmaceutical or above is preferred.

Work experience: Extensive relevant experience in Regulatory Affairs and Quality Assurance at Medical Device companies in Japan. More than 3 years’ experience on similar managerial position.

Required Skills: Track record in management positions with demonstrated problem solving and continuous improvement skills.

Languages: Native Japanese, Fluent English – spoken and written




#LI-DNI

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収1,200 ～ 1,750万円

賞与
-
雇用期間
期間の定めなし