Sr. Regulatory Affairs Coordinator
Our client, a Global Medical Device Manufacture has an immediate opening for a Sr. Regulatory Affairs Coordinator for a 10 Month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
**Fluent Chinese (Mandarin) speaker preferred**
Position Description (Principle Duties and Responsibilities)
Responsible for supporting the implementation of Regulatory Affairs and Quality Assurance systems and procedures relating to Domestic and/or International regulatory requirements.
Provides administrative support to a department or individual. Knowledge of applicable international regulations and standards (QSR, MDD, ISO 13485, CMDCAS, etc.) and willingness to train others in quality assurance/GMP-related topics. Develop and maintain positive relationships with regulatory agencies through professional oral and written communications.
A minimum of a Bachelor s Degree (B.S. Or B.A.) in Science, Engineering, Legal, or Regulatory or related discipline required.
A minimum of 2 years of experience in a FDA regulated industry required.
A minimum of one year in a Regulatory Affairs role required.
Knowledge of FDA Quality System Regulations (21 CFR), EU Medical Device Directives (MDD), and applicable guidance documents preferred.
Experience with international regulations preferred.
Understanding of the FDA device listing and establishment registration process preferred.
Competent with Microsoft Office (Outlook, Excel, Word, etc.).
Excellent analytical and writing skills.