CareerGPS

Regulatory Affairs Specialists
Summary Occupational Forecast Data for Compliance Officers
Employment Employment Change Average Annual Job Openings Wage & Training Levels
2018 2023 Numerical Percent New Jobs Replacement Jobs Total Median Hourly Median Annual Training Levels
409 498 89 21.75% 18 36 54 $34.49 $71,745 Bachelor's degree
Description: Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals or registrations. May compile and prepare materials for submission to regulatory agencies.
Staffing Pattern Data Forecast Data Source: EMSI (2nd Quarter 2018)

Occupation Details

The information in this section represents occupational characteristics included in O*NET which defines key features of an occupation as a standardized, measurable set of variables called "descriptors". These distinguishing characteristics of an occupation are described in greater detail in the O*NET Content Model. All items are listed in descending order of importance.

  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
  • Analyze product complaints and make recommendations regarding their reportability.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, and clinical study compliance issues.
  • Compile and maintain regulatory documentation databases and systems.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes and labeling changes.
  • Develop or conduct employee regulatory training.
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
  • Participate in internal or external audits.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Recommend changes to company procedures in response to changes in regulations or standards.
  • Prepare responses to customer requests for information such as product data, written regulatory affairs statements, surveys, and questionnaires.
  • Review clinical protocols to ensure collection of data needed for regulatory submissions.
  • Write or update standard operating procedures, work instructions, or policies.

Knowledge

85%
English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
79%
Law and Government - Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
55%
Clerical - Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.

Skills

78%
Reading Comprehension - Understanding written sentences and paragraphs in work related documents.
72%
Writing - Communicating effectively in writing as appropriate for the needs of the audience.
72%
Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
69%
Speaking - Talking to others to convey information effectively.
65%
Active Listening - Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
65%
Systems Analysis - Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
65%
Judgment and Decision Making - Considering the relative costs and benefits of potential actions to choose the most appropriate one.
65%
Complex Problem Solving - Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
60%
Systems Evaluation - Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.
60%
Coordination - Adjusting actions in relation to others' actions.
60%
Active Learning - Understanding the implications of new information for both current and future problem-solving and decision-making.
60%
Time Management - Managing one's own time and the time of others.
56%
Social Perceptiveness - Being aware of others' reactions and understanding why they react as they do.
53%
Monitoring - Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
50%
Persuasion - Persuading others to change their minds or behavior.
50%
Negotiation - Bringing others together and trying to reconcile differences.

Abilities

78%
Written Comprehension - The ability to read and understand information and ideas presented in writing.
75%
Written Expression - The ability to communicate information and ideas in writing so others will understand.
72%
Oral Comprehension - The ability to listen to and understand information and ideas presented through spoken words and sentences.
72%
Oral Expression - The ability to communicate information and ideas in speaking so others will understand.
69%
Problem Sensitivity - The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.
65%
Near Vision - The ability to see details at close range (within a few feet of the observer).
65%
Information Ordering - The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
65%
Inductive Reasoning - The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
65%
Deductive Reasoning - The ability to apply general rules to specific problems to produce answers that make sense.
65%
Speech Clarity - The ability to speak clearly so others can understand you.
62%
Speech Recognition - The ability to identify and understand the speech of another person.
60%
Category Flexibility - The ability to generate or use different sets of rules for combining or grouping things in different ways.
56%
Fluency of Ideas - The ability to come up with a number of ideas about a topic (the number of ideas is important, not their quality, correctness, or creativity).
53%
Flexibility of Closure - The ability to identify or detect a known pattern (a figure, object, word, or sound) that is hidden in other distracting material.
50%
Originality - The ability to come up with unusual or clever ideas about a given topic or situation, or to develop creative ways to solve a problem.
50%
Perceptual Speed - The ability to quickly and accurately compare similarities and differences among sets of letters, numbers, objects, pictures, or patterns. The things to be compared may be presented at the same time or one after the other. This ability also includes compa

Work Activities

92%
Evaluating Information to Determine Compliance with Standards - Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
88%
Getting Information - Observing, receiving, and otherwise obtaining information from all relevant sources.
87%
Updating and Using Relevant Knowledge - Keeping up-to-date technically and applying new knowledge to your job.
86%
Interacting With Computers - Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
85%
Communicating with Supervisors, Peers, or Subordinates - Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
83%
Organizing, Planning, and Prioritizing Work - Developing specific goals and plans to prioritize, organize, and accomplish your work.
80%
Processing Information - Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
77%
Establishing and Maintaining Interpersonal Relationships - Developing constructive and cooperative working relationships with others, and maintaining them over time.
77%
Interpreting the Meaning of Information for Others - Translating or explaining what information means and how it can be used.
77%
Making Decisions and Solving Problems - Analyzing information and evaluating results to choose the best solution and solve problems.
76%
Communicating with Persons Outside Organization - Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
76%
Documenting/Recording Information - Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
74%
Identifying Objects, Actions, and Events - Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
68%
Analyzing Data or Information - Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
67%
Performing Administrative Activities - Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.
66%
Developing Objectives and Strategies - Establishing long-range objectives and specifying the strategies and actions to achieve them.
65%
Provide Consultation and Advice to Others - Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.
64%
Coordinating the Work and Activities of Others - Getting members of a group to work together to accomplish tasks.
64%
Developing and Building Teams - Encouraging and building mutual trust, respect, and cooperation among team members.
63%
Scheduling Work and Activities - Scheduling events, programs, and activities, as well as the work of others.
57%
Monitor Processes, Materials, or Surroundings - Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.
57%
Resolving Conflicts and Negotiating with Others - Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.
55%
Training and Teaching Others - Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.
51%
Judging the Qualities of Things, Services, or People - Assessing the value, importance, or quality of things or people.
Title Job Zone Four: Considerable Preparation Needed
Overall Experience A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an accountant must complete four years of college and work for several years in accounting to be considered qualified.
Job Training Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.
Job Zone Examples Many of these occupations involve coordinating, supervising, managing, or training others. Examples include accountants, sales managers, database administrators, teachers, chemists, environmental engineers, criminal investigators, and special agents.
Education Most of these occupations require a four-year bachelor's degree, but some do not.

Interests

Conventional - Conventional occupations frequently involve following set procedures and routines. These occupations can include working with data and details more than with ideas. Usually there is a clear line of authority to follow.
Enterprising - Enterprising occupations frequently involve starting up and carrying out projects. These occupations can involve leading people and making many decisions. Sometimes they require risk taking and often deal with business.

Work Styles

Integrity - Job requires being honest and ethical.
Attention to Detail - Job requires being careful about detail and thorough in completing work tasks.
Dependability - Job requires being reliable, responsible, and dependable, and fulfilling obligations.
Adaptability/Flexibility - Job requires being open to change (positive or negative) and to considerable variety in the workplace.
Analytical Thinking - Job requires analyzing information and using logic to address work-related issues and problems.
Stress Tolerance - Job requires accepting criticism and dealing calmly and effectively with high stress situations.
Initiative - Job requires a willingness to take on responsibilities and challenges.
Persistence - Job requires persistence in the face of obstacles.
Cooperation - Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude.
Achievement/Effort - Job requires establishing and maintaining personally challenging achievement goals and exerting effort toward mastering tasks.

Work Values

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