HireTalent - Diversity Staffing & Recruiting Firm | Regulatory Specialist II | santa clara, ca

4 weeks ago


santa clara, United States HireTalent - Diversity Staffing & Recruiting Firm Full time

Title: Regulatory Specialist II

Location: Santa Clara, CA 95054 (Onsite)

Duration: 12 Months from the start date

Shift Time: 08:00 AM to 5:00 PM

Pay Rate: $45.00/hr. on W2


Duties:

  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Supports manufacturing/operations day to day activities for change control.
  • Provides 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, field support.
  • Applies regulatory and technical knowledge to a wide variety of complex work assignments.
  • Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
  • Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

Requirement:

  • 2 years regulatory experience preferably with medical devices:
  • Knowledge of regulations and standards of medical devices.

Education:

  • BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.



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