61 Responsible for registration of medical device, IVDs and/or drug products. 61 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. 61 Responsible for providing relevant regulatory supports to other company personnel 61 Responsible for establishment of good working relationship with internal and external stakeholders to ensure effective product registrations. 61 Adhere to internal SOP and RA working procedures 61 Provide technical background and input to review cIFU and labeling translation. 61 Ensure that product is compliance with all applicable regulation and Chinese national panel/industry standard. 61 Sr. RA Specialist: Acknowledge the gap between NMPA regulation and EU/FDA regulation to establish the registration strategy.
REQUIREMENTS:
61 Bachelor or above 61 Regulatory Affairs Specialist: 2 yr + Registration or clinical related experiences 61 (Sr.) Regulatory Affairs Specialist: Minimum 4 years registration, clinical or regulatory policy and intelligence working experiences. 61 Good English communication skill 61 Work experience in multi-national company or government affiliates is a plus.
