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.