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The salary of a RAPS RAC-US Certified professional:

The salary of a RAPS RAC-US certified professional varies according to their designation and their employer. According to the salary comparison chart by sector, it is revealed that the average salary of a RAPS RAC-US certified professional is $85,000 per year. A RAPS RAC-US certified professional who passed the exam with the assistance of the RAC-US exam dumps can earn more than an uncertified one. Here is the list of the average salary of the RAPS RAC-US Certified professional:

• In India: 70,000 INR
• In the United States: 85,000 USD
• In Canada: 95,000 CAD
• In the United Kingdom: 75,000 GBP

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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q81-Q86):

NEW QUESTION # 81
You discover that your company's top selling product in the last two years has been used off-label.
The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?

• A. No action is required since it is an off-label use.
• B. Advise the senior management to send a "Dear Dr." letter.
• C. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
• D. Discuss with regulatory authorities to investigate how to have the off-label indication approved.

Answer: D
NEW QUESTION # 82
During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?

• A. ISO 14971 risk analysis
• B. Hazard and operability study
• C. Failure mode and effect analysis
• D. Fault tree analysis

Answer: A
NEW QUESTION # 83
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

• A. Train all new employees on regulatory compliance processes and assign a mentor to them.
• B. Develop documented procedures for regulatory compliance processes and train personnel.
• C. Document any failure to follow regulatory compliance processes in employee performance reviews.
• D. Train employees on all regulatory compliance processes using state-of-the-art systems.

Answer: B
NEW QUESTION # 84
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?

• A. Notify senior management that the product cannot be registered.
• B. Inform the regulatory authority that such a requirement is not applicable to the product.
• C. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
• D. Inform the internal departments to redesign the product to comply with this requirement.

Answer: C
NEW QUESTION # 85
A regulatory affairs professional has submitted a package for regulatory review.
According to the regulation, the regulatory authority will need to respond within 90 days of submission.
If there is no response after the deadline, what is the BEST approach?

• A. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
• B. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.
• C. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
• D. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.

Answer: D
NEW QUESTION # 86
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