- Responsible for registration of medical device, IVDs and/or drug products.
- Responsible for the applications for New Product registration, variations of marketed products and license renewals within the set timeframe and conducting in compliance with NMPA/CMDE requirements as well as relevant internal SOP.
- Responsible for providing relevant regulatory supports to other company personnel
- Responsible for establishment of good working relationship with internal and external stakeholders to ensure effective product registrations.
• Adhere to internal SOP and RA working procedures - Provide technical background and input to review cIFU and labeling translation.
- Ensure that product is compliance with all applicable regulation and Chinese national panel/industry standard.
- Sr. RA Specialist: Acknowledge the gap between NMPA regulation and EU/FDA regulation to establish the registration strategy.
- Bachelor or above
- Regulatory Affairs Specialist: 2 yr + Registration or clinical related experiences
- (Sr.) Regulatory Affairs Specialist: Minimum 4 years registration, clinical or regulatory policy and intelligence working experiences.
- Good English communication skill
- Work experience in multi-national company or government affiliates is a plus
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Medtronic Beijing, 中国Careers that Change Lives · A Day in the Life · Responsibilities may include the following and other duties may be assigned. · Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspect ...
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Kenvue Beijing, 中国Regulatory Affairs Senior Specialist 法规事务高级专员 W Description What you will do · The Regulatory Affairs Senior Specialist is responsible for · Lead China RA Regulatory activities & innovative regulatory area. Build strategic regulatory insights into product registration strateg ...
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Peak Recruitment Beijing, 中国Beijing, China (Hybrid) · Our client is a global leader in providing integrated solutions to the crop science industry. · The Regulatory Affairs Manager APAC is a newly created role for our client's China operations and will be a key role in developing, implementing, and leading ...
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RA Specialist
1周前
Straumann Beijing, 中国 全职· RA Specialist · Main Purpose of the Role · The RA Specialist will be responsible for the routine regulatory affairs and quality assurance of alloted products. · Key Responsibilities · Take charge of all routine registration activities including testing, file preparation, subm ...
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Universal Beijing Resort Tongzhou, 中国 全职Job Summary · Responsible for the development and management of the rigging teams in Universal Beijing Resort. This individual is to provide rigging support to events within the resort, manage system requirements of current and future needs, upgrading of technician skill sets, w ...
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Universal Beijing Resort Tongzhou, 中国 全职Job Summary · Responsible for the development and management of the staging, scenic and props teams in Universal Beijing Resort. This individual is to provide staging, scenic and props support to events within the resort, manage system requirements of current and future needs, u ...
Sr. Regulatory Affairs Specialist - Beijing, 中国 - Abbott
描述
MAJOR RESPONSIBILITIES:
REQUIREMENTS:
