厦门招聘

RA specialist/Supervisor, China（欧美医疗设备行业独资公司，有良好的职业发展前景和海外培训机会，直接向GM汇报）

Location： 上海
SUMMARY
The RA Supervisor, China is responsible for products' registration and relative affairs with SFDA and local SFDA
KEY RESPONSIBILITIES
? Preparation of regulatory submissions, maintenance of registered products and providing input to regulatory strategies, and compliance to major international regulatory standards
? Interface and coordinate with SFDA during inspection or other government agency audits as required
? Reviews and manages resolution of all customer experience reports associated with products
? Interpret existing and/or new regulatory requirements as they relate to company products and procedures.
? Educate, train, & advise company professionals to ensure compliance with regulatory requirements
? Assure all marketing, sales and other materials (e.g. labels) and practices are in conformance with regulatory requirements.
? Other technical and clinical support as required
? Prepare and compile regulatory dossiers for submission to regulatory and government bodies.
? Monitor regulatory activities for the region and implement strategies for regulatory efficacies.
? Liaise with regulatory bodies, internal operations and distributors to understand market trends and regulatory climate.
? Managing compliance of products in accordance with existing regulations and guidelines.
? Resolve licensing and registration issues to allow products to be sold.

EDUCATION, EXPERIENCE, & SKILLS REQUIRED
? Bachelor degree in Engineering, Bioscience or Medicine Science
? 3-5 years of related experience in foreign-invested medical device companies
? High proficiency with practical knowledge in ISO 13485 and USFDA 21 CFR Part 820 requirements with solid experience in US FDA Quality System Regulations and CGMP.
? Excellent communication skills, initiative and ability to work well within a team
? Strong oral and written communication in English and Chinese
? Proactive and independent team player

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