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Greetings! I'm Chandrasekhar, a Staffing Specialist at Intellectt Inc.
Over the past year, we've helped many candidates find careers with medical device companies. Consequently, I am informing you about an exciting job opportunity with one of our clients.
Role: Regulatory Specialist
Location: Lake Forest, IL - 60045
Duration: 12 Months on W2
Shift Timings: 8 AM to 5 PM
Job Description:
- Years Experience: 2+ 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 specialists 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, and 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.
If you are looking for any new opportunities, feel free to reach me at Chandrasekhar@intellectt.com
For quick response reach me at +1732-201-4767
Intellectt INC
