Regulatory Specialist

Contract: Santa Clara, California, US

Salary: $42.00 Per Hour

Job Code: 356107

End Date: 2024-12-19

Days Left: 23 days, 10 hours left

Industry: Pharmaceuticals
Job Title: Regulatory Specialist II
Duration: 12 months [+ Possibilities of extension] 
Location:  Santa Clara, CA 95054
Pay Range - ($37 - $42)/hr
 
Job Roles & Responsibilities: 
  • 2 to 5 years regulatory experience, preferably with medical devices.
  • Knowledge of regulations and standards medical devices.
  • Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
  • Duties: Responsible for implementing and maintaining the effectiveness of the quality system.
  • Supports manufacturing/operations day to day activities for change control.
  • Provides on market support in terms of change control and product development.
  • Provides regulatory direction/interpretation on team activities.
  • Interprets and applies regulatory understanding to support of products and teams.
  • Prepares U.S and EU regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
  • Handles regulatory activities involved in documentation, labeling, and field support.
Job Requirement
  • Quality
  • MDR
  • EUMDR
  • medical device
  • IVD
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Shivani Awasthi
  • shivani.awasthi@collabera.com
Apply Now
Apply Now
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