It’s not uncommon for regulatory affairs and quality assurance to be discussed in the same breath, as though the two industries are the same. But, although the two fields intersect, they are indeed different.
Below, we explore the two fields as they relate to each other, highlight some of the common job titles in each, and take a look at the types of education and skills that can set you up for success in either industry.
Quality Assurance vs. Regulatory Affairs: What’s the Difference?
The line between regulatory affairs and quality assurance can sometimes be difficult to distinguish, but there fundamental differences that set the two disciplines apart.
Regulatory affairs is an industry tasked with overseeing how certain products are developed, tested, manufactured, marketed, and distributed to ensure each process is compliant with the relevant regulatory statutes implemented by various regulatory agencies. Quality assurance, on the other hand, ensures a company’s products meet quality standards for distribution to the market. These include both internal and industry standards, as well as safety standards set by local, state, national, and international governing bodies.
Even with these distinctions in mind, there are still some areas in which these two fields overlap and mirror one another. For example, professionals working in both regulatory affairs and quality assurance are expected to understand and stay abreast of changes in governmental regulations and standards.
There may even be cases when professionals in the two fields are required to work together. For example, a business that manufactures or processes food might employ both regulatory affairs specialists and quality assurance specialists, who may rely on much of the same information, KPIs, and methods, but for different reasons.
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Careers in Regulatory Affairs
Because the regulatory affairs industry plays such a central role in global health, safety, and various medicine, highly skilled regulatory professionals are in high demand across a variety of industries. For this reason, the Bureau of Labor Statistics estimates the field will grow at an average annual rate of eight percent between 2016 and 2026.
If you’re interested in pursuing a career in regulatory affairs, below are some of the most common job titles and salaries.
1. Regulatory Affairs Specialist
Average Salary: $65,586
Regulatory affairs specialists help organizations implement regulatory strategies on local, state, national, and international levels. Their specific responsibilities depend on a number of factors, such as the size of the organization and the industry in which it operates, as each industry is governed by its own system of regulations. Generally, a specialist is responsible for establishing organizational standards in accordance with relevant regulations and monitoring and documenting regulatory compliance.
2. Regulatory Affairs Manager
Average Salary: $99,039
A regulatory affairs manager is responsible for overseeing all teams involved in the production, marketing, and distribution of a product or service to make sure that all are operating in compliance with regulations. As laws and regulations are always changing, it is vital that individuals in this position stay up to date with legislative developments in all areas that have the potential to affect the company’s product or service. Regulatory affairs managers also must regularly advise and strategize with upper management to ensure the organization’s strategic initiatives comply with all applicable laws and regulations.
3. Regulatory Affairs Director
Average Salary: $135,603
A regulatory affairs director oversees an organization’s internal policies and monitors operations to ensure compliance with government regulations. Directors working in a regulatory affairs capacity must have extensive knowledge of the regulations that govern their industry. They typically have many years’ experience working in a regulatory role within their organization.
Careers in Quality Assurance
Because the quality assurance industry is focused on ensuring that all products meet necessary quality standards before landing in the hands of customers, quality assurance specialists can be found working across virtually any industry that develops or manufactures products.
Due to advancements in technology that enable the automation of many manufacturing tasks, the Bureau of Labor Statistics estimates the number of quality control inspectors, who physically inspect products, will decrease by 11 percent between 2016 and 2026. Others job titles, like those below, will remain in demand, as they are more strategic in nature and cannot be easily automated.
1. Quality Assurance Specialist
Average Salary: $57,125
Quality assurance specialist is one of the first titles a professional will hold in the quality assurance career path. This role includes working closely with members of other parts of the organization, such as engineering specialists and management, to identify and remedy any issues with the quality of the product. In addition, these professionals help to strategize and implement procedures to ensure organizational standards are met.
2. Quality Assurance Manager
Average Salary: $77,400
Quality assurance managers are tasked with developing quality assurance standards and practices, as well as monitoring and documenting quality improvements and potential issues. As managers, they are also responsible for supervising teams, and in some cases, hiring and training new employees.
3. Quality Assurance Director
Average Salary: $113,918
More senior-level professionals hold the title of quality assurance director. These professionals work directly with engineers and research and development teams to understand exactly how products are meant to function. The director then works with these teams to create protocols for ensuring that the products are properly tested and work as intended. The main goal of this role is to develop and maintain quality and control processes for the success of the company.
Required Skills and Education
Many of the skills required for careers in regulatory affairs and quality assurance overlap. According to Dr. Stephen Amato, associate teaching professor and lead faculty member for Northeastern’s Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program, to excel in these fields, you must be technically savvy, well-organized, and highly adaptable.
To succeed in either field, it is crucial to be able to use available tools to accurately and efficiently evaluate, measure, document, and communicate compliance with standards and regulations. Accuracy is essential, especially when brand reputation, business investments, and even lives are on the line.
Professionals in these fields must remain up-to-date with the latest technologies to be effective in their roles. Dr. Amato notes that, due to the rapid changes in technologies and legislation, professionals in these fields must always be on the lookout for new information to stay current in their field. Advanced organizational skills can help.
Effective regulatory affairs and quality assurance professionals come from a variety of backgrounds, and there is no single “right” way to get started; however, having an appropriate educational background can help prepare you for the challenges you will face in the field. According to one estimate, 42 percent of regulatory employers prefer candidates with graduate degrees.
Northeastern University’s Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices prepares students to enter into a role where they will need to continuously adapt to new information.
“When students graduate from our program they’re able to use the tools and have the skills necessary to keep learning,” says Amato. “And because of our extensive experiential network, students that come into our program will have plenty of real-world experience to leverage by the time they graduate.”