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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

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