In order to become certified in regulatory affairs, there are a few steps that need to be followed. First, one must complete an accredited regulatory affairs program. Second, pass an examination administered by the Regulatory Affairs Professionals Society (RAPS). Finally, gain at least two years of professional experience in the field of regulatory affairs.
Benefits of completing the Regulatory Affairs Certification
There are several reasons regulatory professions complete this certification program. Benefits of receiving this credential include:
What is the Regulatory Affairs Certification?
There are specific requirements for professionals seeking to obtain this certification because it depends on experience and knowledge in the regulatory field. Depending on an applicant’s education and experience, different criteria apply, including:
How to get a Regulatory Affairs Certification
Review the following actions as a checklist to aid in obtaining your regulatory credentials:
1. Complete higher education
Obtaining a higher education degree, such as a bachelor’s, master’s, or doctorate, can assist you in familiarizing yourself with health care laws. The type of degree you should pursue can be determined by analyzing your career goals. Some degrees you might consider include:
2. Gain regulatory or regulatory-related experience
Getting regulatory or regulatory-related experience can give you insightful knowledge into the laws governing pharmaceuticals and medical devices. There are numerous jobs that can give you this kind of experience. You can also work in positions related to quality assurance, quality control, and clinical research to gain experience in regulatory matters. Some positions to consider include:
Health care compliance with local, state, and federal regulations is audited, monitored, and reported by compliance specialists. These professionals also manage and mitigate health care compliance risks. Additionally, they work together with health care management to assist with and provide guidance on evolving regulations.
A health care organization can obtain and maintain government approval for pharmaceuticals and medical devices with the aid of regulatory affairs specialists. In order to ensure adherence to these regulations, they also explain regulations and policies to an organization’s management team. These analysts also keep track of technical reports and data systems to spot or implement regulatory changes.
Health care organizations, or those handling regulatory-related tasks, are audited for compliance with regulations by regulatory compliance auditors. They also create auditing plans for quarterly, annual, or monthly inspections. These experts also assess the risk faced by an organization and determine strategies for lowering compliance risks.
Healthcare organizations’ electronic and paper records are organized and maintained by medical records specialists. Additionally, these experts confirm file accuracy and assign insurance codes for billing. To ensure adherence to current industry standards, these experts also research current medical records regulations.
Compliance managers ensure an organization remains current with industry regulations. They carry out routine audits, spot compliance issues, and develop plans to reduce compliance risks. To confirm oversight, monitoring, and compliance with regulations, these experts also submit compliance reports to regulatory agencies. To educate new or existing team members about regulatory topics, compliance managers also develop training materials and lead training sessions.
3. Evaluate your examination readiness
It’s crucial to assess your exam readiness because there are two different exam types and four different credentialing regions. Many regulatory experts pass the exam for each area where they work. The United States, Canada, the European Union, and a combination of these regions are among the four regions covered by this exam. You can determine your regulatory strengths and weaknesses by taking practice exams or studying study materials.
4. Prepare for the exam
You can better prepare for each section of the test by reviewing the examination content outlines. The exam consists of 100 questions that assess a person’s knowledge of devices or drugs. Some topics incorporated into the exam include:
5. Complete the RAC examination
Exam registration fees range from $400 to $600. People can complete this certification in person or online at authorized testing facilities. Three examination windows—spring, summer, and fall—are available. It is possible to register for the test by the stipulated deadlines by researching registration windows and timelines. Some common question formats in the exam include:
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How to Get Your Regulatory Affairs Certification | Requirements, Recommendations & more
FAQ
Is a regulatory affairs Certificate worth it?
RAC can make credentialed professionals stand out to prospective employers as an obvious sign of regulatory knowledge that has clear value to employers and clients. Although experience typically outweighs any credentials, an RAC can improve your prospects and, in some cases, make up for a lack of experience.
How do you become a regulatory affairs professional?
- Acquire expertise, experience, and knowledge in a specific area of the industry.
- learn the rules that apply to the goods in that niche.
- Discover how to apply the rules to your chosen subfield’s products.
- Become a member of a regulatory organization.
How difficult is the RAC exam?
You must pass one of two difficult RAC exams in order to obtain the credential. The average pass rate is between 40% and 50%. To pass, you will need to be well-prepared.
What is regulatory certification?
The premier post-academic professional credential for regulatory professionals in the healthcare product industry is the Regulatory Affairs Certification (RAC). It is designed for those working in regulatory organizations, businesses, consulting firms, and other environments where medical devices are regulated.
