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Best regulatory affairs associate certifications
The best certifications for a regulatory affairs associate are Regulatory Affairs Certification - US (RAC), Certified Clinical Research Professional (CCRP), and Certified Clinical Research Associate (CCRA).
Regulatory affairs associate certifications demonstrate your competency as a regulatory affairs associate to employers. However, not all regulatory affairs associate certifications provide the same value.
Below is a list of the best regulatory affairs associate certifications. Obtaining a regulatory affairs associate certification will give you a leg up when you apply for jobs and increase your potential salary.
5 best certifications for regulatory affairs associates
| Rank | Regulatory affairs associate certification | Organization |
|---|---|---|
| 1 | Regulatory Affairs Certification - US (RAC) | RAPS |
| 2 | Certified Clinical Research Professional (CCRP) | SOCRA |
| 3 | Certified Clinical Research Associate (CCRA) | ACRP |
| 4 | Incident Safety Officer - Fire Suppression Certification (ISO) | FDSOA |
| 5 | Certified Quality Auditor (CQA) | ASQ |
5 best regulatory affairs associate certifications
1. Regulatory Affairs Certification - US (RAC)
The RAC (GS) exam is intended for regulatory professionals with 3-5 years of experience and is largely based upon knowledge and application of regulatory functions throughout the healthcare product lifecycle. It covers all product areas, including medical devices, IVDs, pharmaceuticals, medicinal products and biologics. Also covered on the exam are international standards and guidelines including those of ICH, GHTF, WHO and ISO.
- More than two years of education or training after high school required? Yes
- More than two years of work experience required? Yes
- Oral or written exam required? Yes
- Renewal required? Every 3 year(s)
2. Certified Clinical Research Professional (CCRP)
Clinical Research Professionals (CRPs) come from a wide variety of backgrounds. CRPs may have backgrounds in nursing, pharmacy, medical technology, business administration, health record maintenance, statistics, biology, teaching, or in other areas. CRPs work in various settings such as cooperative research groups; academic and private institutions; private offices; pharmaceutical, device, and biotechnology companies; Clinical Research Organizations (CROs); Site Management Organizations (SMOs); independent research and development organizations; or organizations involved in the management of clinical trials. These varying backgrounds and settings contribute to the unique knowledge and diverse expertise of CRPs.
- More than two years of education or training after high school required? Yes
- More than two years of work experience required? Yes
- Oral or written exam required? Yes
- Renewal required? Every 3 year(s)
3. Certified Clinical Research Associate (CCRA)
The CRA exam is a measure of the candidate's general and basic knowledge of the information needed to perform his or her on-job duties and responsibilities effectively. Certification is granted in recognition of the candidate's documented education and working experience as a CRA, and successful completion of the written exam. By granting the designation of CRA, ACRP is formally recognizing the professional CRA who has provided evidence that he or she meets these professional standards.
- More than two years of education or training after high school required? No
- More than two years of work experience required? Yes
- Oral or written exam required? Yes
- Renewal required? Every 2 year(s)
4. Incident Safety Officer - Fire Suppression Certification (ISO)
A fire department incident safety officer's mission is to promote safety standards and practices in the fire, rescue and emergency services community. Members of the Fire Department Safety Officers Association, applicants sponsored by the Authority Having Jurisdiction (AHJ) and individuals meeting the duties and requirements of a company officer or an Incident Scene Safety Officer may apply.
- More than two years of education or training after high school required? No
- More than two years of work experience required? Yes
- Oral or written exam required? Yes
- Renewal required? Every 5 year(s)
5. Certified Quality Auditor (CQA)
The Certified Quality Auditor is a professional who understands the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating and reporting to determine a quality system's adequacy and deficiencies. The Certified Quality Auditor analyzes all elements of a quality system and judges its degree of adherence to the criteria of industrial management and quality evaluation and control systems.
- More than two years of education or training after high school required? No
- More than two years of work experience required? Yes
- Oral or written exam required? Yes
- Renewal required? Every 3 year(s)
What is the best certification for a regulatory affairs associate?
The best regulatory affairs associate certification is Regulatory Affairs Certification - US (RAC). The Regulatory Affairs Certification - US (RAC) is awarded by the Regulatory Affairs Professionals Society. The advanced certification is for more experienced employees as it often requires some work experience to acquire.
Here's a bit more background on how to obtain this regulatory affairs associate certification:
- To become a certified Regulatory Affairs Certification - US (RAC), you need to pass the exam.
- This certificate requires more than two years of work experience.
- Renew certification every 3 year.
What certifications can impact a regulatory affairs associate career and salary?
The Regulatory Affairs Certification - US certification will help you to secure a regulatory affairs specialist position, which will increase your pay and career trajectory. A regulatory affairs specialist's average salary is $64,314 whereas regulatory affairs associates make an average salary of $71,154.
The most common combination of regulatory affairs associate certifications include: Regulatory Affairs Certification - US (RAC), Certified Clinical Research Professional (CCRP), and Certified Clinical Research Associate (CCRA).
Online courses for regulatory affairs associates to earn certifications
1. Regulatory Compliance
Every organization faces a myriad of risks that can threaten its operations, reputation, and bottom line. A robust, effective compliance program can make the difference between companies that successfully navigate those risks, and those that become cautionary tales.\n\nThis specialization will introduce the essential elements of effective organizational compliance by exploring the concepts, considerations, and strategies for assessing risks and managing the compliance function. You will learn...
2. Clinical Trials Operations
This specialization is designed for individuals and teams that will be running or interacting with clinical trials. In four courses, learners will develop insights and build the skills they need to design, manage, and monitor clinical trials as well as analyze, document, and communicate the results. Learners will also learn best practices regarding ethics, safety, participant recruitment, regulatory compliance, and reporting standards. The core principles and skills of the specialization will...
3. Pharmaceutical Industry Drug Regulatory Affairs (DRA)
Empowering Professionals in the Pharmaceutical Industry: A Comprehensive Online Course in Drug Regulatory Affairs...
4. Certificate Course in Drug Regulatory Affairs (DRA)
Pharma course (NDA, ANDA, CTD, DMF, USFDA, Regulatory strategy, GMP, Clinical Research, Orange Book, Pharmaceuticals)...
5. FinTech Law and Policy
Being a successful FinTech firm requires more than just great technology; it also requires an understanding of the laws and regulations applicable to your business. This course will provide you with that understanding. You will learn about the critical legal, regulatory, and policy issues associated with cryptocurrencies, initial coin offerings, online lending, new payments and wealth management technologies, and financial account aggregators. In addition, you will learn how regulatory agencies...
6. Drug Development
The University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Drug Development course brings you lectures from both faculty and industry experts. With this course, recorded on campus at UCSD, we seek to share our access to top people in the field who bring an unprecedented range of expertise on drug development. In this course you will learn the different stages of clinical development as well as the regulatory including but not limited to, an Investigational New...
7. Practical Regulatory Affairs 2020 - US FDA Medical Devices
A practical course discussing the US FDA Medical Device regulations for real-world situations...
8. EU Medical Device Regulatory Affairs explained Simply
How to get approval to sell Medical Devices within the European Union. Understand regulatory affairs & ISO 13485 2016...
9. Introduction to Medical Software
In this class, we present a broad overview of the field of medical software. You will learn from Yale professors and a series of industry experts who connect the course concepts to their real world applications. We begin by discussing medical device regulatory structures, data privacy and cybersecurity regulations, and key support technologies such quality management systems and risk management. We then take a detailed look at the medical software life cycle, starting with identifying user...
10. Practical Regulatory Affairs 2020 - European Medical Devices
A practical course discussing the EU Medical Device Regulation (MDR) in real-world situations...
11. Pharma Drug Regulatory Affairs Certificate Course - DRA 2023
DRA, Orange book, USFDA, e CTD, CTD, INDA, NDA, ANDA, DMF, ICH, Software Demo, RA Jobs, Quiz, Pharma Skills, Updated 2023...
12. Medical Device Regulation 2017/745 EU regulatory affairs.
Understand regulations for medical devices in simple terms to gain market approval of a medical device in the EU...
13. ISO 13485 Demystified - Medical Devices' QMS 360° Insights
Deep dive into the world of ISO 13485 international standard for medical devices' QMS, basic concepts & requirements...
14. The Simplest Guide to Clinical Trials Data Analysis with SAS
Step into the world of Pharmaceutical industry Clinical Trials Clinical Research Biostatistics Clinical SAS SAS...
15. ISO 13485 - IQOQPQ - Process Validation for Medical Devices
Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ) Medical Devices...
16. Medical Device Process Validation. ISO 13485. IQ OQ PQ.
Validate a process to gain approval to sell medical devices in the EU, U.S. & Internationally. Compliance to ISO 13485...
17. Medical Devices Quality Management System - ISO 13485:2016
Awareness and Application for the requirements of ISO 13485:2016 for Medical Device Development and QMS...
18. Internal audit on Medical Device QMS - ISO 13485:2016
Successfully conduct an internal audit based on requirements of ISO 13485:2016 for Medical Device Development and QMS...
19. Certificate Course in Pharmacovigilance
Drug safety, Drug development and discovery, ICSR , Adverse events, Global guidelines, Med DRA, PV Audits...
20. ISO 13485:2016 - Design and Development of Medical Devices
Design and Development of Medical Devices in the perspective of ISO 13485:2016 and Medical Devices Industry...