Regulatory Affairs Specialist
Location : Upper Saddle River NJ US 07458
Job Type : Temp/Contract
Reference Code : 20395-BZ1
Compensation : open - 55-65/h
Start Date : 12/15/2020
Hours : Full Time
Required Years of Experience : 2
Required Education : BS Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- Contract position for a Regulatory Affairs Specialist to support Regulatory Affairs product life cycle management and sustaining activities, specifically focused on OUS registrations.
- Compilation of documentation that may be required for China regulatory submissions.
- Interfacing with different functions (R&D, clinical, etc.) to obtain necessary documentation.
- Becoming acquainted with Chinese medical device standards and regulations.
- Support of various Chinese regulatory submission types, including new product registrations, change registrations, and extensions.
- Review of China submission documentation to ensure the Chinese standards and relevant regulatory requirements are met.
- Reporting project status and progress to management and/or project lead. Must be proficient in Microsoft office (Work, Excel, Outlook).
Required Qualifications :
- BS Engineering or Healthcare related field preferred.
- Minimum 2 years of Regulatory, Quality or R&D experience in an FDA regulated industry.
- Experience interacting with Other Health Authorities Preferred.
- Strong communication skills and experience in cross functional teams are necessary.
Contact: Bill Zukowsky