614462
Our client, a leading Medical Device company in Alameda, CA, is looking for a Regulatory Affairs Specialist II to provides consultation / advice to regulatory specialist for change control and product development.
Required Skills :
- 2-5 years regulatory experience and / or 2 years relevant industrial experience typically with a quality, product-development / support, or scientific affairs function
- BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
- Medical Device Background required
- Experience writing regulatory submissions required
Responsibilities :
- 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.
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Supports manufacturing / operations day to day activities for change control.
Compensation within this range will be commensurate with level of experience
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