RAC US Braindumps

1. Pass Your RAC US Exam On The First Attempt By Dumpsbook RAC US Exam Questions

2. RAC US Regulatory Affairs Certification If you are a regulatory professional considering pursuing Regulatory Affairs Certification (RAC), you are not alone. RAC is a recurring topic of discussion in online forums where regulatory professionals and those looking to get into the profession ask questions and exchange ideas, such as the Regulatory Open Forum on RAPS' Regulatory Exchange, the RAPS LinkedIn group discussion or Elsmar Cove. You may be wondering what the return on investment of getting the RAC will be, or whether you are ready to take one of the challenging RAC exams? The answers to these questions depends largely on you. Variables to consider include the amount of regulatory experience you have, potential additional credibility to be gained, the level of support you have from your employer and how much time you can devote to studying. So while there is no one-size-fits-all answer to the question ‘Is the RAC right for me?,’ there are some important factors to take into account. First, you should know why you want to get your RAC and what you hope to gain from having it. Do you want increased credibility, a higher salary or a new job? RAC can be a significant contributing factor to all these goals if you are in a position to leverage it. Are you trying to break into regulatory from another field? In that instance, you should take a hard look at your background and experience to determine if RAC is a good fit. The exams are experience-based and intended for professionals with 3–5 years in the regulatory field. If you are new to regulatory or short on experience, there may be better ways to invest in your career now, while you work toward taking the RAC exam once you gain additional experience (see Other Options below).  https://www.dumpsbook.com/Exam/RAC-US

3. Question: 1 You work for a German-based device manufacturer (Company A) that produces a power supply based on a US-based medical device company's (Company B) design. The power supply is imported into your company's US-based manufacturing site (Company C) for further processing and then sent to the US-based medical device company (Company B) for final assembly. Which company needs to register with FDA A. Company A B. Company B C. Company A &B D. Company A, B &C Answer: B https://www.dumpsbook.com/Exam/RAC-US

4. Question: 2 The following biological products are regulated by CBER EXCEPT: A. Immunizing toxoids B. Monoclonal antibodies for in vitro use C. Monoclonal antibodies for in vivo use D. Infusion of animal sourced cells into a human Answer: C https://www.dumpsbook.com/Exam/RAC-US

5. Question: 3 A company is developing a new device and the classification under which it would fall is unclear. As the regulatory professional, you would submit the following: A. 510(k) Premarket Notification B. Request for Designation C. 513(g) Request for Information D. Type A Meeting Request Answer: C https://www.dumpsbook.com/Exam/RAC-US

6. Question: 4 Your company's commercial product is manufactured by a third-party manufacturer (TPM). The manufacturing site undercharges one of the excipients. Without contacting your company, the TPM decides to rework the batch and now would like the product to be released upon completion of the investigation. Your technical team contacts you for regulatory advice on whether the lot can be released upon approval of the investigation. As a regulatory professional, as a first step you: A. Recommend the lot be released B. Recommend the lot not be released C. Assess whether the rework steps are within the regulatory filing and whether there is a potential regulatory impact D. If the rework steps are not in the current filing, submit a postapproval change to include the rework steps in order to release the material Answer: C https://www.dumpsbook.com/Exam/RAC-US

7. Question: 5 A company's competitor is marketing a Class II suture that dissolves during the third week of use. The company's current product has to be removed by a physician. However, a change in weaving configuration gives this product the same dissolving time as the competitor's. What needs to be done for the company to market this new dissolving suture? A. Filing a new 510(k) documenting changes in product instructions for use B. Submission of changes in a periodic report C. After-reporting clinical studies in an Annual Report D. After-submission of labeling change Answer: A https://www.dumpsbook.com/Exam/RAC-US

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