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5-7年经验 -
招1人 -
英语熟练 -
11-09 发布
职位描述
职位描述： Responsibilities:Response to gather all medical regulation and for new project transferringResponse for the production re-registration and manufacture license revise periodicallyParticipation as Regulatory Affairs Part in local R&D projectsEnsure that regulatory authorities’ requirements are met for products engineered and manufacturedAlong with project engineer, ensures that each product complies with local, regional, and/or national registration, safety, and other required approvals before product are delivered to the customerEvaluation and implementation of Design Change Requirement/Design Change Order(DCR/DCO) on products produced in ChinaMake short term and long term plan on product registration and product innovationPost market support: to keep the compliance to the regulatory in different marketMonitor the Medical device regulatory in different main market, and keep effectiveness of regulatory in local site and to the products.Requirement:Bachelor degreeMore than 5 years RA experience in Medical device or Pharmaceutical industryExperience including international Regulatory Affairs is a plusFamiliar with ISO 13485 and 9001 standards and FDA 21 CFR 820Good problem solving skillsTeam player and stable personalityMature and independentResponsible and take accountabilityFluent in English 职能类别： 医疗器械注册 关键字： RA Medical
联系方式
厦门
公司信息
Sphere established in 1998 years. Up to now, Sphere have a successful track recorder to our client which include 500 fortune company, successful position include senior management, technical engineering, research and development, marketing and sales etc. Sphere won support and trust from our client depend on our high working effect.
