可替代职业名称:Medical Product Manager, Regulatory Affairs Associate, or related
是否为正常职业要求:Y
是否需要外语:N
特殊技能:Bachelors or foreign equivalent degree in Biomedical Engineering, PharmacyPharmacology, BiochemistryImmunobiology, Regulatory AffairsScience or in a closely related regulatory affairs, quality, or biological science field with at least 3 years of experience in i ensuring and coordinating compliance with quality management system regulatory requirements for medical devices throughout product lifecycle, including ISO 13485, FDA 21 CFR 820, EU MDD, and equivalent local regulations for medical devices; ii providing regulatory representation and support for quality management system and product lifecycle change management; iii preparing, submitting, and maintaining domestic and international technical files, product registrations and licensing applications for Class II or higher medical devices; and iv understanding, investigating, and evaluating regulatory historybackground of class, disease therapeuticdiagnostic context to assess regulatory implications for approval, and determining trade issues to anticipate regulatory obstacles.