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 #1

Position summary

The Regulatory Compliance Specialist, as part of the Quality team will interact with every level and groups in the organization including external customers. The Specialist must be able to work independently without a set day-to-day schedule to ensure regulatory and quality requirements are met and drive product quality via manufacturing process improvements and customer satisfaction.

Key job responsibilities

  • Involved in the recall/correction process, drafting of notices, and own action plan if a recall is necessary
  • Draft customer notifications and work with appropriate parties to distribute
  • Coordinate/co-facilitate customer audits and associated activities
  • Assist in regulatory audits in any needed capacity
  • Own regulatory compliance submissions and coordination for approval
  • Serve as Quality contact for any supplier issues or changes
  • Perform customer audits as needed
  • Serve as subject matter expert to assist with marketing content, technical support, and review of materials (customer facing quality document owner)
  • Compile, review, and submit any applications for use (510k through FDA, FCC, CE, etc.)
  • Ensures that integration or product onboarding project goals are met
  • Participate in internal audit program
  • Model personal Lean Philosophy 5S behaviors in creating a continuously improving, clean, well-organized and self-maintaining work environment
  • Follow a continuous improvement approach for achieving high performance SQDC (Safety, Quality, Delivery, and Cost) targets through a visual work environment
  • Comply with company ethics, code of conduct, policies, and best practices, with a commitment to safety in the workplace, valuing of diversity, and promotion of a harassment-free environment
  • Perform other duties as assigned by management

Education

  • Bachelor of Science Degree

Experience and required skills

  • Minimum 4 years of experience in a regulated manufacturing environment
  • Previous experience with ISO 13485:2016
  • Experience with 510(k) submissions preferred
  • History of FDA/regulated audit involvement
  • Excellent communication skills; written and verbal
  • Quality Assurance Process, Audit and Control and testing
  • Experience and training in lean development and lean problem solving desirable
  • Change management

Sample job description #2

The Regulatory Specialist is responsible for promoting compliance with the regulatory requirements within ABC Company’s departments.

  • Meets with the Regulatory department to organize deliverables and reviews materials
  • Interacts with and represents the Clinical Vendor Management and Oversight department to auditors and responds to auditor requests
  • Identifies organizational risks and helps implement process improvements
  • Manages, coordinates, and participates in the implementation of contract changes for all lines of business pertaining to delegated vendors. Ensures that all process and by delegated vendors are in compliance with State and Federal regulations
  • Reviews the delegated vendors policies, procedures, and correspondence to ensure compliance with CMS and DOH regulations
  • Monitors all Corrective Action Plans (CAPs) through completion
  • Reviews timeliness of all monitoring reports to assess for compliance with regulatory time frames and develops CAPs for same if out of compliance
  • Assists in accreditation submissions, regulatory surveys, and internal audits
  • Additional duties as assigned

Minimum qualifications

  • High School Diploma or GED

Preferred qualifications

  • Bachelor’s degree from an accredited institution
  • Previous relevant compliance experience
  • Proficiency with Microsoft systems like Outlook, Excel, and Word

Sample job description #3

Working without significant direction, assists in fulfilling Regulatory compliance requirements by applying a thorough understanding of Regulatory standards to one or more areas of expertise such as regulations for medical devices.

Essential duties

  • Using a broad base of knowledge and understanding of regulatory requirements, assumes major responsibility for one or more major regulatory affairs areas
  • Identifies and defines contents for Regulatory filings/dossiers. Leads the assembly and creation of these documents for their timely submission to Regulatory authorities.
  • Maintenance of sometimes complex existing licenses/certificates, product approvals, and simple post market notifications
  • Responsible for overall compliance with Regulatory requirements that apply to the product development cycle. Makes recommendations on how to achieve compliance
  • Works with manufacturing, engineering, and other functional groups on Regulatory compliance issues
  • Applies standard procedure and learned knowledge to develop regulatory solutions of moderate to low complexity within established guidelines. May collaborate with individuals at different levels in solving problems, and recommends modifications to operating policies where appropriate
  • The effect of Regulatory support offered to internal customers may be critical to the short-term and intermediate objectives of the department

Education

  • Bachelor’s degree in physical/biological sciences or engineering preferred, or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered

Experience

  • Minimum 4 years experience in Regulatory Affairs

Skills

  • In depth knowledge of U.S. and/or international medical device and/or pharmaceuticals and/or biologics regulations and standards
  • Working knowledge of and ability to prepare regulatory documentation in compliance with regional regulatory requirements
  • Familiarity with regulatory standards and demonstrates general knowledge with individual products/geographies
  • Demonstrated ability to author sections of a regulatory submission under supervision, with content review at end
  • Qualified within the Regulatory function with limited to moderate understanding of the basic principles, theories, practices, and concepts within the Regulatory function
  • Recognize and awareness of gaps and potentially suggest solutions.
  • Able to identify adequacy of sections and overall content of submissions
  • Knowledge and use of relevant PC software applications and skills to use them effectively
  • Demonstrated ability to communicate effectively both verbally and and in writing
  • Must be highly skilled in timely and accurate decisions
  • Demonstrated analytical and creative thinking skills and the ability to solve complex problems

Certificates, licenses, registrations

  • Quality Assurance or Regulatory Affairs Certification (RAC) desired

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.

LocationSalary LowSalary High
Phoenix, Arizona$95,000$128,500
Los Angeles, California$107,150 $144,950
Denver, Colorado$89,300$120,800 
Washington, DC$108,800$147,150
Miami, Florida$88,900 $120,250
Orlando, Florida$82,000 $110,900 
Tampa, Florida$82,800$112,000
Atlanta, Georgia$86,850$117,500 
Chicago, Illinois$99,850$135,100 
Boston, Massachusetts$107,950$146,050
Minneapolis-St. Paul, Minnesota$86,050 $116,400 
New York City, New York$113,650$153,750
Philadelphia, Pennsylvania$92,550 $125,200 
Dallas, Texas$90,100 $121,900
Houston, Texas$89,300 $120,800
Seattle, Washington$103,900 $140,600
National Average$81,200 $109,850 

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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