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Regulatory Specialist Career Guide

If you love making sure companies are meeting all regulations that pertain to their business, then becoming a regulatory specialist could be for you. Depending on the industry, you may be customer-facing or client-facing. Other times, you may be working alone, ensuring all federal, state, and local regulations are met. As a regulatory specialist, you will be responsible for dealing with customers within an organization, prioritizing their needs, and supporting them as needed. Regulatory specialists work in a variety of industries. You will often be conducting regular audits, reviewing the company’s documents and business transactions, renewing permits and licenses, and submitting necessary files to ensure the business stays on track. You must have strong analytical skills, knowledge of regulations, and a passion for staying organized.

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.

Preferred qualifications

  • Able to quickly adapt to changes in regulatory law as they develop
  • Strong communication skills
  • 2+ years of experience

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.

Typical hours

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.

Available certifications

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.

Career path

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

2020 Employment557,900
Projected Employment in 2030489,800
Projected 2020-2030 Percentage Shift 12% decrease
Projected 2020-2030 Numeric Shift68,100 increase

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.