Regulatory Specialist Ii

3 weeks ago


Santa Clara, United States Validation Associates Full time

**Description**:
**Experience**: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function Skills: Knowledge of regulations and standards affecting IVDs and/or biologics

**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 consultation/advice to regulatory specialist for 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. 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.

**Job Type**: Contract

Pay: Up to $58.00 per hour

Schedule:

- 8 hour shift

**Experience**:

- international regulations: 2 years (required)

Work Location: On the road



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