Regulatory SpecialistJob Description, Salary, Career Path, and Trends
Regulatory specialists ensure that organizations meet all state, local, federal, international, and industrial regulations that apply to their products. They generally work in the food and beverage, pharmaceutical, and medical devices industries, though other companies that require regulatory compliance, such as those that produce automotive or mechanical components, also employ regulatory specialists.
Regulatory specialists should have strong analytical, project management, and communication skills. They must have experience in a regulatory position, complying with local, state, and federal regulations, presenting to regulatory authorities, and work well under strict deadlines.
Sample job description
Here at [Your Company Name], we prioritize thoroughness, attention to detail, and above all else an unbending commitment to consumer safety and satisfaction. It is the job of a regulatory specialist to help corporations and organizations comply with all regulations pertaining to the products they manufacture, market, and/or distribute. This includes international regulations, federal regulations, and state regulations, in addition to the regulations governing specific industries. A competent regulatory specialist must possess a good memory and a keen eye for minutiae. Our regulatory specialists are expected to familiarize themselves with all relevant regulations so as to ensure that our products are held to the highest possible standard at all times.
Typical duties and responsibilities
Interviewing executives, managers, and employees to determine compliance-related priorities.
Providing advice on regulatory affairs requirements for all proposed changes to device design.
Ensuring product design and R&D development teams adhere to regulatory controls.
Building and maintaining strong partnerships with regulatory authorities.
Addressing customer issues and concerns and ensuring repetitive occurrences do not occur.
Ensuring continuous compliance for all products.
Compiling regulatory submissions to regulatory and consumer agencies.
Overseeing inspection/audit activities and following up on any required actions assigned.
Creating and implementing quality systems improvements.
Ensuring compliance records are properly maintained.
Maintaining and updating documentation, processes, and practices.
Coordinating regulatory compliance procedures across organizational structures.
Providing training in compliance practices and procedures.
Keeping up to date on regulatory changes and developments in the regulatory environment.
Education and experience
Bachelor’s degree in Biology, Chemistry, other science fields, or in the field of regulatory specialization.
5+ years experience in a relevant industry.
3+ years experience as a regulatory compliance specialist.
Required skills and qualifications
Extensive knowledge of industry regulations and governing laws.
Proficient in office and compliance management software.
Strong analytical, investigative, and organizational skills.
Excellent attention to detail.
Solid interpersonal and communication skills.
Excellent written and verbal communications skills.
Ability to effectively negotiate with regulatory, technical, medical, and legal professionals.
Strong computer skills and Microsoft Office skills.
Ability to work under pressure.
Able to quickly adapt to changes in regulatory law as they develop
Strong communication skills
2+ years of experience
Average salary and compensation
The average salary for a Regulatory Specialist is $95,500 in the United States. Position salary will vary based on experience, education, company size, industry, and market.
Los Angeles, California
Minneapolis-St. Paul, Minnesota
New York City, New York
Typical work environment
Regulatory specialists work in a variety of fields, but the majority of their time will be spent in an office no matter what industry they work in. They will usually be sorting through documents and making sure all the products are passing inspection. They will typically work regular business hours but occasionally may work holidays depending on the industry they work in.
Regulatory specialists typically work in an office setting in front of a computer. They mostly work between 9:00 AM and 5:00 PM Monday through Friday but might occasionally have to work evenings and weekends to meet deadlines.
Though it’s not required that regulatory specialists receive certifications, it can help them stand out from the rest of the crowd. Some popular ones are:
Certified Clinical Research Professional. In order to earn this certification, you must first submit a written application to the Society of Clinical Research Associates’ certification program. If your written application is accepted, you will then be given a written exam. The label of CRP (Clinical Research Professional) has a great deal of utility and can be put to use by professionals from a wide range of backgrounds, including business administration, statistics, nursing, and pharmacology. In addition to the written application and the exam, more than two years of education or training after high school and more than two years of work experience are also required. Please note that this certification must be renewed every three years.
Regulatory Affairs Certification. In order to earn this certification, you must first take a two-part written exam designed to test your knowledge of medicinal products and medical devices, in addition to your comprehension of international regulations that apply to the field of healthcare. In addition to the exam, more than two years of education or training after high school and more than two years of work experience are also required. Please note that this certification must be renewed every three years.
To pursue a career as a regulatory specialist, you’ll need a bachelor’s degree in product safety, biology, chemistry, or another related field. Many companies prefer candidates who hold a graduate degree. To advance in a career to a senior-level position as a regulatory specialist, you need a number of years of experience and generally a master’s degree. Hands-on experience is critical for those hoping to advance in their careers. Many VP’s in the industry have upwards of 15 years of experience. Continuing education is also an important aspect of a career as a regulatory specialist as new regulations and technologies are continually being created.
US, Bureau of Labor Statistics’ job outlook
SOC Code: 11-9199
Projected Employment in 2030
Projected 2020-2030 Percentage Shift
Projected 2020-2030 Numeric Shift
Medical device regulation is evolving due to healthcare practitioners obtaining devices such as pacemakers and insulin through Bluetooth or the cloud. This brings up cybersecurity concerns and how the FDA and regulatory agencies around the world will develop regulations for manufacturers in relation to new data security standards. With the rise of off-label drug use in the US, legislation has lagged behind in implementing regulatory approvals.
This, along with the COVID pandemic, has brought about discussions as to how the FDA will go about approving new drug products sooner. Patient input in clinical trials is becoming more important in the FDA and other regulatory agencies reporting outcomes in the drug approval process. Where in the past, agencies relied more on lab tests like blood panels and urinalysis, they are now moving toward analyzing how a patient feels during a clinical trial and basing their decisions on that data. The FDA is also undergoing a digital transformation, advancing digital health priorities to keep pace with trends in digital health and data analytics.
Sample interview questions
“The letter of the law is less important than the spirit of the law.” Do you consider this statement to be true or false?
Can you point to an example in recent years of an organization failing to adhere to externally enforced regulations, be they international, federal or otherwise? What were the consequences for that organization? What should it have done differently, in your view?
You have just learned that [Your Company Name] is due to be audited. What is the first thing that you do in order to prepare us for this impending audit?
You have just identified some way in which [Your Company Name] is guilty of regulatory noncompliance. How would you go about conveying this oversight to the relevant authorities within and without [Your Company Name]?
Are you a capable communicator in your personal and professional life? Can you name a time when you successfully explained a complex issue to a layperson who did not share your expertise?
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