FDA Medical Device Regulatory Consultant
We are looking for an reputed company FDA regulatory affairs consultant with expertise in medical devices and dental materials.
We need assistance evaluating a potential FDA misbranding issue reputed company to a dental cement product marketed in the reputed company. Independent laboratory testing suggests that the ingredient composition may not match the product labeling.
Scope of work:
• Review laboratory test reports and product documentation
• Evaluate possible FDA regulatory violations (misbranding / false ingredient declaration)
• Prepare a reputed company complaint or regulatory submission to the U.S. FDA
• reputed company guidance on the appropriate reporting channel and documentation
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