Newark, United States
almost 2 years ago
Provides regulatory strategy to project teams to enable successful registration of new IVDs in U.S., EU, Japan and worldwide. Utilizes regulatory strategy including replacement reagent to ensure new devices are compliant with FDA regulations. Ensures compliance with FDA requirements by either submission or note-to-files. Submits CLIA categorization.
Reviews promotional material and device labeling to ensure accuracy and regulatory compliance. Guides regulatory projects, project schedules, and product introduction process.
Guides the decision making process on regulatory submission issues using historical knowledge, legal counsel and FDA's current regulations on medical device industry.
- BA/BS in Science, Engineering or related discipline or advanced degree.
- In-depth knowledge of FDA regulations on medical devices with preference for IVDs.
- In-depth knowledge of design control, risk management techniques in bringing a new device to the market.
- 8-10 years of experience in regulatory field and successful demonstration of applying regulatory knowledge to successfully bring new products to market.
- Displays a high level of critical thinking in bringing successful resolution to high-impact, complex, and/or cross-functional problems.