Job Summary
A clinical and scientific staffing company is searching for a person to fill their position for a Remote Medical Device Regulatory Senior Specialist.
Candidates will be responsible for the following:
- Being responsible for implementing and maintaining the effectiveness of the quality system
- Supporting manufacturing/operations day to day activities for change control
- Providing consultation/advice to regulatory specialist for change control and product development
Must meet the following requirements for consideration:
- Knowledge of regulations and standards affecting IVDs and/or biologics
- 2+ years regulatory experience
- And/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function
- Ability to handle regulatory activities involved in documentation, labeling, field support
- Ability to apply regulatory and technical knowledge to a wide variety of complex work assignments
- Ability to maintain and ensure compliance to the appropriate quality system for the specific medical device(s) designed or manufactured
