RAPS RAC Regulatory Affairs Certification RAC-US

Short on study time for the RAPS Regulatory Affairs Certification (RAC) US exam? Getcertkey condenses your preparation into 100 focused practice questions for the RAC-US exam, so even a packed schedule leaves room for steady, measurable progress.

RAPS RAC-US Exam Overview:

Certification Vendor:	Regulatory Affairs Professionals Society (RAPS)
Exam Name:	Regulatory Affairs Certification (RAC) US
Exam Number:	RAC-US
Related Certifications:	RAC-Global RAC-Canada RCC RAC-EU
Exam Duration:	120 minutes
Exam Format:	Computer-based, Multiple-choice, Application, Analysis, Recall
Available Languages:	English
Real Exam Qty:	100
Certificate Validity Period:	3 years
Exam Price:	USD 605 (RAPS Member), USD 760 (Non-Member)
Passing Score:	Scaled score of 75
Sample Questions:
Exam Way:	Pearson VUE Test Center or Online Proctored Exam (OnVUE)
Pre Condition:	Bachelor's degree and 3 years regulatory experience; or Master's degree and 2 years regulatory experience; or Doctorate degree and 1 year regulatory experience.
Official Syllabus URL:	https://www.raps.org/certifications/rac

RAPS RAC-US Exam Syllabus Topics:

Common Questions About the RAPS RAC-US Exam

What is the RAPS Regulatory Affairs Certification (RAC) US exam all about?

The RAC-US exam is the official Regulatory Affairs Professionals Society (RAPS) exam behind the RAC Regulatory Affairs Certification certification, validating the skills measured by the RAPS Regulatory Affairs Certification (RAC) US credential. It sits at the Professional level of the Regulatory Affairs Professionals Society (RAPS) certification program. It also connects to RAC-Global, RAC-EU, RAC-Canada, RCC, so the knowledge you build here carries over to those tracks as well.

How many questions are on the RAC-US exam, and how much time do I get?

The RAC-US exam contains 100 questions to be completed within 120 minutes. Before exam day, divide the available time by the question count to work out a comfortable per-question pace, and mark any item that eats into it so you can return later instead of getting stuck. Timed sessions in the Getcertkey test engines make that pacing automatic — run at least two full-length mock exams under the clock so time pressure never becomes the reason you drop points.

What score do I need to pass the RAC-US exam, and what does it cost?

The passing score for the RAC-US exam is Scaled score of 75, and the official registration fee is USD 605 (RAPS Member), USD 760 (Non-Member). Retakes are not discounted — every new attempt means paying the full fee again — so it pays to measure yourself before you book. Work through the 100 practice questions on Getcertkey, sit a timed practice test, and schedule your exam only when your scores are consistently comfortable. That simple habit is the cheapest exam strategy there is.

Are there any prerequisites for the RAC-US exam?

Bachelor's degree and 3 years regulatory experience; or Master's degree and 2 years regulatory experience; or Doctorate degree and 1 year regulatory experience. Requirements can change when Regulatory Affairs Professionals Society (RAPS) revises its certification program, so confirm the current eligibility rules on the official exam page before you register.

Can I try the RAC-US practice questions before I buy?

Yes. Getcertkey provides a free RAC-US PDF demo so you can review the question style and answer quality before purchasing. Every purchase also includes 365 days of free updates — if RAPS revises the exam during that period, the updated material reaches you at no cost. Once the free-update year ends, you can extend your update service at a 50% discount.

What if I fail the RAC-US exam, and how is my order delivered?

Every RAPS Regulatory Affairs Certification (RAC) US purchase on Getcertkey is covered by a 100% money-back guarantee with clear conditions: if you take the corresponding exam within 60 days of your purchase and do not pass, you can claim a full refund by submitting a scanned copy of your exam enrollment slip and your official score report as a PDF within two days of the exam date; claims are processed within seven days of submission. The guarantee does not apply to exams taken within three days of purchase, to material that was downloaded but never used in an exam attempt, or to free products and expired orders, and the candidate name must match the payer name. If you would rather not take a refund, you can instead exchange your purchase for two free exam preparation products of equal value and keep the update service on your original product.

Delivery is instant: your download is sent to your email within one minute of payment, with no limit on how many computers you may install the material on. If nothing arrives within two hours, check your spam folder and contact customer service for help.

What topics are covered in the RAC-US exam?

The RAPS Regulatory Affairs Certification (RAC) US exam blueprint is organized into 4 domains. The first three are:

• Strategic Planning
• Interfacing with Regulatory Agencies
• Premarketing

For the complete domain-by-domain breakdown, scroll up to the full exam topics outline above and use it to plan how you distribute your study time.

RAPS Regulatory Affairs Certification (RAC) US Sample Questions:

Question #1
A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?

A. Obtain a copy of the proposed regulation and analyze the impact.
B. Consult with the company's legal department regarding options.
C. Inform the company's senior management and arrange an emergency meeting
D. Arrange for additional testing of the product at the testing facility.

Question #2
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

A. Malfunction protection operated correctly
B. Deficiency of a device found by the user prior to patient use
C. Adverse event caused by patient conditions
D. Malfunction occurring before the end of service life of the medical device

Question #3
The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

A. Analytical
B. Regulatory
C. Production
D. Quality

Question #4
According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?

A. Risk analysis
B. Risk management
C. Risk estimation
D. Risk control

Question #5
A company is developing a line of products for which no ISO standard of performance is available. As a result, the company wishes to propose developing such a standard. Whom should the company contact in order to start the development of the new standard?

A. The ISO Secretariat
B. The ISO technical committee in charge of the area
C. The country's regulatory authority
D. The ISO national member body

Solutions: