Regulatory Specialist II
4 weeks ago
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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