Easter Seals Jobs

MAJOR RESPONSIBILITIES:

• 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.

REQUIREMENTS:

• 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

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com